Allogeneic Transplantation Using TL1 & ATG for Older Patients With Hematologic Malignancies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00185640
First received: September 12, 2005
Last updated: April 9, 2014
Last verified: April 2014

September 12, 2005
April 9, 2014
March 2003
June 2016   (final data collection date for primary outcome measure)
To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GV/HD) occurs. [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00185640 on ClinicalTrials.gov Archive Site
  • To evaluate the incidence and extent of chronic GVHD. [ Time Frame: Unknown ] [ Designated as safety issue: No ]
  • To document the quantitative and qualitative reconstitution of the immune system including T cell subsets, NK cells and B cells. [ Time Frame: Unknown ] [ Designated as safety issue: No ]
  • To evaluate the rate of relapse, overall and event-free survival and transplant related mortality rate. [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]
  • To evaluate the kinetics of donor hematopoietic cell engraftment and chimerism. [ Time Frame: Unknown ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Allogeneic Transplantation Using TL1 & ATG for Older Patients With Hematologic Malignancies
Allogeneic Hematopoietic Cell Transplantation Using a Non-Myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Older Patients With Hematologic Malignancies

To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GV/HD) occurs.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Blood Cancer
  • Leukemia
  • Drug: cyclosporine
    3-5 mg/kg BID; IV or oral
    Other Names:
    • cyclosporin
    • cyclosporin A
  • Drug: Thymoglobulin
    7.5-10 mg/kg; IV
    Other Name: Anti-thymocyte globulin
  • Drug: mycophenolate mofetil
    15 mg/kg BID or Q 8 hours
    Other Names:
    • MMF
    • CellCept
  • Drug: g-csf
    16 mcg/kg; SQ
    Other Names:
    • Granulocyte colony-stimulating factor
    • gcsf
    • colony-stimulating factor 3
    • csf 3
Experimental: Non-myeloablative transplantation
Interventions:
  • Drug: cyclosporine
  • Drug: Thymoglobulin
  • Drug: mycophenolate mofetil
  • Drug: g-csf
Kohrt HE, Turnbull BB, Heydari K, Shizuru JA, Laport GG, Miklos DB, Johnston LJ, Arai S, Weng WK, Hoppe RT, Lavori PW, Blume KG, Negrin RS, Strober S, Lowsky R. TLI and ATG conditioning with low risk of graft-versus-host disease retains antitumor reactions after allogeneic hematopoietic cell transplantation from related and unrelated donors. Blood. 2009 Jul 30;114(5):1099-109. Epub 2009 May 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
June 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

(A) Any patient with one of the following hematolymphoid malignancies or syndromes in whom allogeneic NST is warranted. Specific disease categories include: indolent advanced stage Non-Hodgkin Lymphomas, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia, Hodgkin Disease, Acute Leukemias in complete remission, Aplastic Anemia, Paroxysmal Nocturnal Hemoglobinuria, and, Myelodysplastic and Myeloproliferative Syndromes. Patients with other selected malignancies/disorders may also be considered but must be approved by the transplant team and the Principal Investigator.

(B) Patient age > 50 years, or for patients <50 years of age but because of pre-existing medical conditions or prior therapy are considered to be at high risk for regimen-related toxicity associated with conventional myeloablative transplants.

(C) A fully HLA-identical sibling or matched unrelated donor is available. Patients with one antigen mismatched donors can be considered but only after discussion with the transplant team and the Principal Investigator.

(D) Patient must be competent to give consent.

Exclusion Criteria:

(A) Patients with progressive hematolymphoid malignancies despite conventional therapies, or acute leukemias not in complete remission.

(B) Uncontrolled CNS involvement with disease

(C) Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment

(D) Females who are pregnant

(E) Organ dysfunction defined as follows:

  • Cardiac function: ejection fraction <30% or uncontrolled cardiac failure
  • Pulmonary: DLCO <40% predicted
  • Liver function abnormalities: elevation of bilirubin to > 3 mg/dl and/or transaminases >4x the upper limit of normal
  • Renal: creatinine clearance <50 cc/min (24 hour urine collection)

(F) Karnofsky performance score < 60%

(G) Patients with poorly controlled hypertension on multiple antihypertensives

(H) Documented fungal disease that is progressive despite treatment

(I) Viral infections: HIV positive patients. Hepatitis B and C positive patients will be evaluated on a case by case basis

(J) Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.

Both
up to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00185640
BMT153, 78998, BMT153, 11960
Yes
Stanford University
Stanford University
Not Provided
Principal Investigator: Robert Lowsky Stanford University
Stanford University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP