Clinical trial · Interventional
Carmustine, Etoposide, Cytarabine, Melphalan, and Alemtuzumab Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
A Phase II Study of Reduced Intensity Allogeneic Transplantation for Refractory Hodgkin Lymphoma
- 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)
RATIONALE: Giving chemotherapy before a donor 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. Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect. PURPOSE: This phase II trial is studying the side effects of giving carmustine together with etoposide, cytarabine, melphalan, and alemtuzumab followed by donor stem cell transplant and to see how well it works in treating patients with relapsed or refractory Hodgkin lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| carmustine | Drug | Carmustine | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| cytarabine | Drug | Cytarabine | ALIAS |
| donor lymphocytes | Biological | — | UNRESOLVED |
| etoposide | Drug | Etoposide | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival at 3 years
Secondary outcomes (8)
- measure
- Donor engraftment rates, including chimerism at 3 and 6 months
- measure
- Non-relapse mortality at 100 days, 1 year, and 2 years post-transplant
- measure
- Incidence of grade II-IV toxicity as assessed by NCI CTCAE v3.0
- measure
- Incidence, severity, and timing of acute and chronic graft-versus-host disease
- measure
- Response rates
- measure
- Relapse rates
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Confirmed diagnosis of Hodgkin lymphoma, meeting 1 of the following criteria: * Refractory to initial multi-agent induction therapy and achieved less than a complete response to one line of salvage chemotherapy * In first relapse and achieved less than a partial response to one line of salvage chemotherapy * No progressive disease * Must have an HLA-matched (≥ 9/10) sibling or unrelated donor available PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Creatinine clearance ≥ 50 mL/min * Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2 times ULN * LVEF ≥ 40% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2-3 months after completion of study treatment * No HIV positivity * No other malignancy within the past 5 years, except for nonmelanoma skin cancer or stage 0 (in situ) cervical carcinoma * No concurrent serious medical condition that would preclude an allograft * No symptomatic respiratory compromise PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior high-dose therapy or allograft
References
Publications (1)
- DERIVEDDas-Gupta E, Thomson KJ, Bloor AJC, Clark AD, Mackinnon S, Kayani I, Clifton-Hadley L, Patrick P, El-Mehidi N, Lawrie A, Kirkwood AA, Russell NH, Linch DC, Peggs KS. Allo-HSCT in transplant-naive patients with Hodgkin lymphoma: a single-arm, multicenter study. Blood Adv. 2019 Dec 23;3(24):4264-4270. doi: 10.1182/bloodadvances.2019001016. PMID 31869413