Phase 2
Completed N=64
Gemcitabine Hydrochloride, Clofarabine, and Busulfan Before Donor Stem Cell Transplant in Treating Patients With Refractory B-Cell or T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma
Hematopoietic Cell Transplantation Recipient · Non-Hodgkin's Lymphoma · Hodgkin lymphoma
Source: ClinicalTrials.gov NCT01701986 ↗
Enrolled (actual)
64
Serious AEs
20.3%
Results posted
Feb 2025
Primary outcomePrimary: Optimal Dose of Gemcitabine Hydrochloride Determined by Dose Limiting Toxicity — 0; 6; 20; 0 Participants
Summary
This phase I/II trial studies the side effects and best dose of gemcitabine hydrochloride, clofarabine, and busulfan before donor stem cell transplant and to see how well it works in treating patients with B-cell or T-cell non-Hodgkin lymphoma or Hodgkin lymphoma that does not respond to treatment. Giving chemotherapy before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Optimal Dose of Gemcitabine Hydrochloride Determined by Dose Limiting Toxicity |
0; 6; 20; 0; 0; 0 | — |
| PRIMARY Number of Participants That Had 100 Day Success Rate Post Transplant |
6; 17; 21 | — |
| SECONDARY Overall Survival |
2; 8; 14 | — |
| SECONDARY Treatment Related Mortality |
2; 1; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with refractory B-cell or T-cell non-Hodgkin's lymphoma or Hodgkin's lymphoma who are eligible for allogeneic transplantation
- An 8/8 human leukocyte antigen (HLA) matched (high resolution typing at A, B, C, DRB1) sibling or unrelated donor
- Left ventricular ejection fraction (EF) >= 45%
- Forced expiratory volume in one second (FEV1) >= 50%
- Forced vital capacity (FVC) >= 50%
- Diffusing capacity of the lung for carbon monoxide (DLCO) >= 50%
- Estimated serum creatinine clearance >= 50 ml/min (using the Cockcroft-Gault formula)
- Serum creatinine = = 10, 000 copies/mL, or >= 2,000 IU/mL)
- Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology
- Human immunodeficiency virus (HIV) infection
- Active uncontrolled bacterial, viral or fungal infections
- Exposure to other investigational drugs within 2 weeks before enrollment
- Grade >= 3 non-hematologic toxicity from previous therapy that has not resolved to =< grade 1
- Radiation therapy to head and neck (excluding eyes), and internal organs of chest, abdomen or pelvis in the month prior to enrollment
- Prior whole brain irradiation
- Prior autologous stem-cell transplant (SCT) in the prior 3 months
Data sourced from ClinicalTrials.gov (NCT01701986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.