Clinical trial NCT01596257: Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation
Official title: Randomized Phase II Trial of Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Keywords: CliniMACS-CD34 Reagent System
Acute Leukemia
Myelodysplastic syndrome
Non Hodgkins Lymphoma
Hodgkins Disease
Multiple Myeloma
12-016
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 116
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Patients whose donor fails to collect the appropriate number of cells will receive all their cells as a bulk infusion. These patients will continue to receive a transplant on protocol but will be replaced until both arms have reached the target accrual.

Eligibility criteria: Inclusion Criteria:

* Patients who are considered candidates for an allogeneic stem cell transplantation as treatment for any of the following hematologic disorders:
* Acute Leukemia
* Myelodysplastic syndrome
* Other myeloproliferative disorder (i.e. myelofibrosis, chronic myelomonocytic leukemia, or chronic myelogenous 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

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 Program Manual, document E-1 see http://mskweb5.mskcc.org/intranet/html/80312.cfm
* 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

Primary outcomes:
measure: Median Time to Engraftment of Neutrophils
timeFrame: Up to 100 weeks
Secondary outcomes:
measure: Number of Participants Assessed for Toxicities
timeFrame: 2 years
measure: Median Time to Platelet Engraftment
timeFrame: Up to 365 days
measure: Overall Survival
timeFrame: 24 months
measure: Hematopoietic Function on Day 30
timeFrame: 30 days
measure: Hematopoietic Function on Day 180
timeFrame: 180 days
measure: Hematopoietic Function on Day 360
timeFrame: 360 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Sergio Giralt, MD
role: PRINCIPAL_INVESTIGATOR
References: