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Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00096161
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : May 4, 2017
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Brenda Sandmaier, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Graft Versus Host Disease
Hodgkin Lymphoma
Myelodysplastic/Myeloproliferative Neoplasm
Non-Hodgkin Lymphoma
Plasma Cell Myeloma
Waldenstrom Macroglobulinemia
Interventions Drug: Cyclosporine
Drug: Mycophenolate Mofetil
Drug: Pentostatin
Biological: Therapeutic Allogeneic Lymphocytes
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1A (Pentostatin, DLI Dose Level 1) Group 1B (Pentostatin, DLI Dose Level 2) Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS) Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Hide Arm/Group Description

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Period Title: Overall Study
Started 20 10 6 0
Completed 20 10 6 0
Not Completed 0 0 0 0
Arm/Group Title Group 1A (Pentostatin, DLI Dose Level 1) Group 1B (Pentostatin, DLI Dose Level 2) Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS) Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS) Total
Hide Arm/Group Description

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Total of all reporting groups
Overall Number of Baseline Participants 20 10 6 0 36
Hide Baseline Analysis Population Description
No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 6 participants 0 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
0
   0.0%
Between 18 and 65 years
17
  85.0%
7
  70.0%
4
  66.7%
0
28
  77.8%
>=65 years
3
  15.0%
3
  30.0%
2
  33.3%
0
8
  22.2%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 10 participants 6 participants 0 participants 36 participants
55
(44 to 67)
59.3
(35 to 72)
60.3
(47 to 69)
56.9
(35 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 6 participants 0 participants 36 participants
Female
2
  10.0%
2
  20.0%
1
  16.7%
5
  13.9%
Male
18
  90.0%
8
  80.0%
5
  83.3%
31
  86.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 10 participants 6 participants 0 participants 36 participants
20 10 6 36
1.Primary Outcome
Title Percentage Patients With an Increase of at Least 10 Percentage Points in Donor T-cell Chimerism
Hide Description

A regimen will be considered successful if 20 patients are enrolled, at least 13 demonstrate improved chimerism. If fewer than 5 patients have shown improvement in chimerism then it can be at least 75% confident that the true rate of improvement is less than 0.53. Enrollment to the regimen will stop and the next regimen will be opened. Enrollment to a regimen may also be stopped at any time it becomes impossible to achieve 5 of 10 or 13 of 20 successful improvements.

"Chimerism" in hematopoietic cell transplant derives from this idea of a "mixed" entity, referring to someone who has received a transplant of genetically different tissue. A test for chimerism after a hematopoietic cell transplant involves identifying the genetic profiles of the recipient and of the donor and then evaluating the extent of mixture in the recipient's blood cells or marrow cells.

Time Frame From the time of enrollment maintained to day 56 after the last DLI, up to Day 112
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
Arm/Group Title Group 1A (Pentostatin, DLI Dose Level 1) Group 1B (Pentostatin, DLI Dose Level 2) Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS) Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Hide Arm/Group Description:

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Overall Number of Participants Analyzed 20 10 6 0
Measure Type: Number
Unit of Measure: percentage of participants
60 30 33.3
2.Primary Outcome
Title Incidence of Grade IV Acute GVHD
Hide Description

Clinical Stage of acute GVHD according to Organ System

Skin:

  1. - Maculopapular rash <25% of body surface
  2. - Maculopapular rash 25-50% of body surface
  3. - Maculopapular rash >50% body surface area or generalized erythroderma
  4. - Generalized erythroderma with bullous formation and desquamation

Liver:

  1. - Bilirubin 2-3 mg/dl
  2. - Bilirubin 3.1-6 mg/dl
  3. - Bilirubin 6.1-15 mg/dl
  4. - Bilirubin >15 mg/dl

Gut:

  1. - >500-1000 mL diarrhea per day or (nausea, anorexia or vomiting with biopsy (EGD) confirmation of upper GI GVHD
  2. - >1000 -1500 mL diarrhea per day
  3. - >1500 mL diarrhea per day
  4. - >1500 mL diarrhea per day plus severe abdominal pain with or without ileus

Overall Clinical Grading of Severity of acute GVHD Grade IV: 0-4 Skin, 2-4 Liver, and/or 2-4 GI

Time Frame Within 100 days after the last DLI
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
Arm/Group Title Group 1A (Pentostatin, DLI Dose Level 1) Group 1B (Pentostatin, DLI Dose Level 2) Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS) Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Hide Arm/Group Description:

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Overall Number of Participants Analyzed 20 10 6 0
Measure Type: Number
Unit of Measure: percentage of participants
5 0 0
3.Secondary Outcome
Title Incidence of GVHD
Hide Description

Percentage patients with acute or chronic GVHD.

The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.

Time Frame 1 year after DLI
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
Arm/Group Title Group 1A (Pentostatin, DLI Dose Level 1) Group 1B (Pentostatin, DLI Dose Level 2) Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS) Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Hide Arm/Group Description:

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Overall Number of Participants Analyzed 20 10 6 0
Measure Type: Number
Unit of Measure: percentage of participants
aGVHD 20 0 0
cGVHD 50 20 16.7
4.Secondary Outcome
Title Incidence of Infections
Hide Description [Not Specified]
Time Frame 100 days after DLI
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
Arm/Group Title Group 1A (Pentostatin, DLI Dose Level 1) Group 1B (Pentostatin, DLI Dose Level 2) Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS) Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Hide Arm/Group Description:

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Overall Number of Participants Analyzed 20 10 6 0
Measure Type: Number
Unit of Measure: percentage of participants
80 70 33.3
5.Secondary Outcome
Title Incidence of Relapse/Progression
Hide Description

CML Acquisition of a new cytogenetic abnormality and/or development of accelerated phase or blast crisis. Criteria for accelerated phase: unexplained fever >38.3° C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, BM blasts and promyelocytes >20%.

AML, ALL, CMML >30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia.

CLL Progressive disease: ≥1 of: physical exam/imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.

NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.

MM

≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ tx; or definite increase in the size/number of plasmacytomas or lytic bone lesions.

Time Frame 1 year after DLI
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
Arm/Group Title Group 1A (Pentostatin, DLI Dose Level 1) Group 1B (Pentostatin, DLI Dose Level 2) Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS) Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Hide Arm/Group Description:

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Overall Number of Participants Analyzed 20 10 6 0
Measure Type: Number
Unit of Measure: percentage of participants
45 20 33.3
6.Secondary Outcome
Title Survival
Hide Description Percentage patients surviving.
Time Frame 1 year after DLI
Hide Outcome Measure Data
Hide Analysis Population Description
No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
Arm/Group Title Group 1A (Pentostatin, DLI Dose Level 1) Group 1B (Pentostatin, DLI Dose Level 2) Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS) Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Hide Arm/Group Description:

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Overall Number of Participants Analyzed 20 10 6 0
Measure Type: Number
Unit of Measure: percentage of participants
60 90 66.7
Time Frame AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Adverse Event Reporting Description One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
 
Arm/Group Title Group 1A (Pentostatin, DLI Dose Level 1) Group 1B (Pentostatin, DLI Dose Level 2) Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS) Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Hide Arm/Group Description

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.

Pentostatin: Given IV

Therapeutic Allogeneic Lymphocytes: Given IV

All-Cause Mortality
Group 1A (Pentostatin, DLI Dose Level 1) Group 1B (Pentostatin, DLI Dose Level 2) Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS) Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Group 1A (Pentostatin, DLI Dose Level 1) Group 1B (Pentostatin, DLI Dose Level 2) Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS) Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/20 (30.00%)      0/10 (0.00%)      0/6 (0.00%)      0/0    
Blood and lymphatic system disorders         
Anemia   1/20 (5.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
Hemolytic uremic syndrome   1/20 (5.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
Cardiac disorders         
Atrial fibrillation   1/20 (5.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
Immune system disorders         
GVHD   1/20 (5.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
Nervous system disorders         
Peripheral motor neuropathy   1/20 (5.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
Respiratory, thoracic and mediastinal disorders         
Hypoxia   1/20 (5.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1A (Pentostatin, DLI Dose Level 1) Group 1B (Pentostatin, DLI Dose Level 2) Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS) Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/20 (50.00%)      2/10 (20.00%)      2/6 (33.33%)      0/0    
Blood and lymphatic system disorders         
Anemia   1/20 (5.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
Febrile neutropenia   1/20 (5.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
Hemolysis   1/20 (5.00%)  1 0/10 (0.00%)  0 1/6 (16.67%)  1 0/0  0
Thrombotic thrombocytopenic purpura   1/20 (5.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
Cardiac disorders         
Cardiac troponin I increased   1/20 (5.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
Gastrointestinal disorders         
Gastric hemorrhage   2/20 (10.00%)  3 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
Ileal obstruction   1/20 (5.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
General disorders         
Fever   0/20 (0.00%)  0 1/10 (10.00%)  1 0/6 (0.00%)  0 0/0  0
Infections and infestations         
Small intestine infection   1/20 (5.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
Investigations         
Blood bilirubin increased   2/20 (10.00%)  2 0/10 (0.00%)  0 1/6 (16.67%)  1 0/0  0
Creatinine increased   1/20 (5.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
Forced expiratory volume decreased   1/20 (5.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
Investigations - Other, (Pancytopenia)   1/20 (5.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
Renal and urinary disorders         
Acute kidney injury   1/20 (5.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
Respiratory, thoracic and mediastinal disorders         
Hypoxia   3/20 (15.00%)  3 1/10 (10.00%)  1 0/6 (0.00%)  0 0/0  0
Vascular disorders         
Hypotension   2/20 (10.00%)  2 0/10 (0.00%)  0 0/6 (0.00%)  0 0/0  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Brenda M. Sandmaier
Organization: Fred Hutchinson Cancer Research Center
Phone: (206) 667-4961
EMail: bsandmai@fhcrc.org
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Responsible Party: Brenda Sandmaier, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00096161    
Other Study ID Numbers: 1825.00
NCI-2010-00230 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1825.00 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P01CA078902 ( U.S. NIH Grant/Contract )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: November 9, 2004
First Posted: November 9, 2004
Results First Submitted: January 27, 2017
Results First Posted: May 4, 2017
Last Update Posted: January 31, 2020