Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation
This study is currently recruiting participants.
Verified May 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01596257
First received: May 9, 2012
Last updated: May 16, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to find out if getting a blood stem cell transplant with donor stem cells given over several days is better than getting a blood stem cell transplant with donor stem cells given over 1 day. We want to find out which procedure over will result in improved recovery of blood and immune function after transplant. When donor stem cells are given over various days in mice, the blood and immune system recovery is quicker.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: 8 x 10e6 CD34+ cells per kg Biological: 4 x 10e6 CD34+ cells per kg |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase II Trial of Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- neutrophil recovery [ Time Frame: 2 years ] [ Designated as safety issue: No ]Determine the effects of fractionated vs. bulk stem cell infusions on neutrophil recovery as defined by number of days with an absolute neutrophil count of less than 500 neutrophils per micro liter and time to an absolute neutrophil count (ANC) of 500.
Secondary Outcome Measures:
- safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Toxicities will be graded on a scale of 0 to 4 as described by the NCI-Common Terminology for Adverse Events (CTCAE), version 4.0.
- immune- reconstitution [ Time Frame: 1 year ] [ Designated as safety issue: No ]The area under the hematopoietic recovery curve for the factors: ALC, CD4, CD8, and platelet count. The area under the curve will be computed based on recordings at days 30, 60, 100, 180, 365.
- on bacterial, viral, and fungal infections during the first 100 days post transplant [ Time Frame: 100 days post days transplant ] [ Designated as safety issue: No ]The time to ALC 500, and the time to first bacterial, viral, and fungal infection will be computed using the cumulative incidence function and a comparison between groups will be undertaken using Gray's test.
- hematopoietic function [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]Determine the effect of fractionated vs bulk CD34 selected stem cell infusions on hematopoietic function as determined by platelet counts and cumulative platelet transfusion requirements on days 30, 60 and 100, 6 and 12 months post transplant.
| Estimated Enrollment: | 72 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Patients targeted to receive 8 x 10e6 CD34+ cells per kg
This is a randomized Phase II trial of bulk versus fractionated stem cell infusions in patients with hematologic malignancies undergoing allogeneic stem cell transplantation. Patients will be stratified by type of transplant (T cell depletion vs no T cell depletion).
|
Biological: 8 x 10e6 CD34+ cells per kg
Patients targeted to receive 8 x 10e6 CD34+ cells per kg on the day of the transplant. This is a complex study that involves various interventions, Intervention #1: Donor Initial Stem Cell Collection; Intervention #2: Stem Cell Product Initial Processing Orders; Intervention #3 Patient Admission and Transplantation; Intervention #4: Stem cell infusion; Intervention #5: Post infusion follow up; Intervention #6: Off Study Patient and Donor Evaluation.
|
|
Experimental: Patients targeted to receive 4 x 10e6 CD34+ cells per kg
This is a randomized Phase II trial of bulk versus fractionated stem cell infusions in patients with hematologic malignancies undergoing allogeneic stem cell transplantation. Patients will be stratified by type of transplant (T cell depletion vs no T cell depletion).
|
Biological: 4 x 10e6 CD34+ cells per kg
Patients targeted to receive 4 x 10e6 CD34+ cells per kg on the day of the transplant and then receive three supplemental infusions on days 2, 4, and 6 post SCT. This is a complex study that involves various interventions, Intervention #1: Donor Initial Stem Cell Collection; Intervention #2: Stem Cell Product Initial Processing Orders; Intervention #3 Patient Admission and Transplantation; Intervention #4: Stem cell infusion; Intervention #5: Post infusion follow up; Intervention #6: Off Study Patient and Donor Evaluation.
|
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients who are considered candidates for an allogeneic stem cell transplantation as treatment for any of the following hematologic disorders:
- Acute Myeloid Leukemia
- Myelodysplastic syndrome
- Other myeloproliferative disorder (i.e. myelofibrosis, chronic myelomonocytic leukemia, or chronic myelogenous leukemia)
- Acute Lymphoblastic Leukemia
- Non Hodgkins Lymphoma
- Hodgkins Disease
- Multiple Myeloma
- Age includes from birth to < 75 years old.
- Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status > 70%
- Patients must have adequate organ function measured by:
- Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > 40%
- Hepatic: < 5x ULN ALT and < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
- Renal: serum creatinine <1.5 mg/dl or if serum creatinine is outside the normal range, then CrCl > 40 ml/min (measured or calculated/estimated)
- Pulmonary: asymptomatic or if symptomatic, DLCO > 40% of predicted (corrected for hemoglobin).
Exclusion Criteria:
- Female patients who are pregnant or breast-feeding.
- Active viral, bacterial or fungal infection
- Patient seropositive for HIV-I/II; HTLV -I/II
- Presence of leukemia in the CNS
- Candidate for a protocol of higher priority. For the purpose of this study, the following protocols will be considered of higher priority: 10-051, 08-008.
Donor Inclusion Criteria
- HLA compatible related or unrelated donor, (i.e. a fully matched unmanipulated grafts or 1-2 HLA allele disparate donor for CD34 selected grafts).
- Meets criteria outlined in the FACT-approved SOP for "DONOR EVALUATION AND SELECTION FOR ALLOGENEIC TRANSPLANTATION" in the Blood and Marrow Transplant
- Donor must have adequate peripheral venous catheter access for leukapheresis or must agree to placement of a central catheter.
- Wt >25kg
Donor Exclusion Criteria
- Evidence of active infection (including urinary tract infection, or upper respiratory tract Infection) or viral hepatitis exposure (on screening), unless only HBS Ab+ and HBV DNA negative.
- Medical or physical reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis.
- Factors which place the donor at increased risk for complications from leukapheresis or GCSF therapy (e.g., autoimmune disease, sickle cell trait, symptomatic coronary artery disease requiring therapy).
- Pregnancy (positive serum or urine β-HCG) or breastfeeding. Women of childbearing age must avoid becoming pregnant while on the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596257
Contacts
| Contact: Sergio Giralt, MD | 212-639-6009 | |
| Contact: Richard O'Reilly, MD | 212-639-5956 |
Locations
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Sergio Giralt, MD 212-639-6009 | |
| Contact: Richard O'Reilly, MD 212-639-5956 | |
| Principal Investigator: Sergio Giralt, MD | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Sergio Giralt, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01596257 History of Changes |
| Other Study ID Numbers: | 12-016 |
| Study First Received: | May 9, 2012 |
| Last Updated: | May 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
CliniMACS-CD34 Reagent System Acute Myeloid Leukemia Myelodysplastic syndrome Acute Lymphoblastic Leukemia |
Non Hodgkins Lymphoma Hodgkins Disease Multiple Myeloma 12-016 |
Additional relevant MeSH terms:
|
Leukemia Hematologic Neoplasms Neoplasms by Histologic Type |
Neoplasms Neoplasms by Site Hematologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013