Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT02570542
This study examines the effect of CD34+ stem cell dose on outcomes post-autologous transplant in DLBCL patients. Eligible participants, aged ≥18, with specific health criteria, will undergo leukapheresis and plerixafor mobilization. Randomized groups receive varying stem cell doses, followed by BEAM chemotherapy and ASCT, with standard supportive care provided.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to study the impact of stem cell dose on outcome after autologous transplant.
Description
Following enrollment, patients will be CD34+ stem cell mobilized at the discretion of the treating attending physician with the plerixafor for the achievement of >6 x10^6 CD34+ cells/kg. The patients that fail to mobilize >6 x10^6 CD34+ cells/kg will not be randomized and will subsequently be followed for disease progression and overall survival.. Patients with >6 x10^6 CD34+ cells/kg cryopreserved on study will be admitted to the hospital for planned ASCT. Patients will be randomly infused with either 3-4 x 10^6 CD34+ stem cells/kg or 6-8 x10^6 CD34+ stem cells/kg on d0 per study randomization. The cell dose ranges within the two groups allows variability within aliquots of cells at the time of cryopreservation. Patients will receive standard supportive measures (including: growth factor support post-HDT/ASCT, antimicrobial prophylaxis, red blood cell and platelet transfusion and treatment for neutropenic fever) as per institutional guideline practices.
Eligibility Criteria
Inclusion Criteria
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Age ≥ 18 years old
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Diagnosed with relapsed or refractory de novo DLBCL or follicular lymphoma transformed to DLBCL to one previous line of anthracycline-containing chemotherapy
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KPS ≥ 70
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Complete or partial response by IWG Working Group or ICML Criteria to maximum of one salvage line of chemotherapy without pre-HDT/ASCT salvage radiotherapy.
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Eligible for high-dose therapy and autologous stem-cell rescue
- Serum creatinine ≤ 1.5 mg/dL, or if creatinine >1.5 mg/dL, calculated creatinine clearance of ≥50 mL/min by 24 hour creatinine clearance or CKD-EPI.
- Last cycle of most recent salvage therapy within 8 weeks of enrollment
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Total bilirubin < 2.0 mg/dL
o If Gilbert"s disease is suspected and total bilirubin > 2.0 mg/dL, direct bilirubin must be < 2.0 mg/dL
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Females of childbearing potential and males must agree to use an acceptable form of contraception per institutional practices.
Exclusion Criteria
- Disease progression by IWG Working Group or ICML Criteria since last therapy
- Prior autologous or allogeneic stem cell transplantation
- HIV infection
- Comorbid condition(s) which, in the opinion of the attending physician and/or MSKCC Principal Investigator, will preclude stem cell mobilization and/or high-dose therapy with autologous stem cell rescue
- Treatment plan that includes post-transplant maintenance therapy
- Salvage therapy that includes involved field radiotherapy
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Nebraska Medical Center | 68198-7680 | Omaha | Nebraska |
| Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up Only) | Basking Ridge | New Jersey | |
| Memorial Sloan Kettering Monmouth (Consent and Follow up Only) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Consent and Follow Up Only) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Commack (Consent and Follow-up Only) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester | 10604 | Harrison | New York |
| Northwell Health (Data collection only) | 11030 | Manhasset | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Columbia University | New York | New York | |
| University of Rochester Medical Center | 14642 | Rochester | New York |
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