Clinical trial · Interventional
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)
A Multi-center Randomized Phase II 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)
NCT02570542CI-TRIAL-00098006active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to study the impact of stem cell dose on outcome after autologous transplant.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| Refractory Diffuse Large B-cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.78 |
| Relapsed Diffuse Large B-cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| carmustine, etoposide, cytarabine, melphalan | Drug | — | UNRESOLVED |
| leukapheresis | Procedure | — | UNRESOLVED |
| Plerixafor | Drug | Plerixafor | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 3-4 x 10^6 CD34+ stem cells/kg
- description
- 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.
- interventionNames
- Procedure: leukapheresis
- Drug: Plerixafor
- Drug: carmustine, etoposide, cytarabine, melphalan
- Procedure: Autologous Stem Cell Transplantation
- type
- EXPERIMENTAL
- label
- 6-8 x10^6 CD34+ stem cells/kg
- description
- 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.
- interventionNames
- Procedure: leukapheresis
- Drug: Plerixafor
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old * Diagnosed with relapsed or refractory de novo DLBCL or follicular lymphoma transformed to DLBCL to one previous line of anthracycline-containing chemotherapy * KPS ≥ 70 * 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. * 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 * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.