Carmustine, Etoposide, Cytarabine, Melphalan, and Alemtuzumab Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: alemtuzumab Biological: donor lymphocytes Drug: carmustine Drug: cyclosporine Drug: cytarabine Drug: etoposide Drug: melphalan Procedure: allogeneic hematopoietic stem cell transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Reduced Intensity Allogeneic Transplantation for Refractory Hodgkin Lymphoma |
- Progression-free survival at 3 years [ Designated as safety issue: No ]
- Donor engraftment rates, including chimerism at 3 and 6 months [ Designated as safety issue: No ]
- Non-relapse mortality at 100 days, 1 year, and 2 years post-transplant [ Designated as safety issue: No ]
- Incidence of grade II-IV toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Incidence, severity, and timing of acute and chronic graft-versus-host disease [ Designated as safety issue: No ]
- Response rates [ Designated as safety issue: No ]
- Relapse rates [ Designated as safety issue: No ]
- Response to donor lymphocyte infusions [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 47 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To document the toxicity and feasibility of reduced-intensity conditioning regimen comprising carmustine, etoposide, cytarabine, melphalan, and alemtuzumab followed by allogeneic hematopoietic stem cell transplantation in patients with primary refractory or relapsed Hodgkin lymphoma.
- To document the survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Conditioning regimen: Patients receive BEAM chemotherapy comprising carmustine IV over 2 hours on day -6, etoposide IV over ≥ 1 hour on days -5 to -2, cytarabine IV over 15 minutes twice daily on days -5 to -2, and melphalan IV on day -1. Patients also receive alemtuzumab IV on days -5 to -1.
- Allogeneic hematopoietic stem cell transplantation (HSCT): Patients undergo allogeneic HSCT on day 0.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV (or orally once tolerable) beginning on day -1 and continuing until day 60, followed by a taper in the absence of GVHD.
- Donor lymphocyte infusion (DLI): Patients with mixed chimerism or stable residual disease at 6 months after HSCT or disease progression or relapse at any time after HSCT may receive DLI in the absence of GVHD.
After completion of study treatment, patients are followed periodically for 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00908180 History of Changes |
| Other Study ID Numbers: | CDR0000640493, CRUK-PAIReD, EUDRACT-2008-004956-60, EU-20930, UCL/08/0121 |
| Study First Received: | May 22, 2009 |
| Last Updated: | June 9, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
recurrent adult Hodgkin lymphoma |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Carmustine Melphalan Etoposide phosphate Alemtuzumab Cytarabine Etoposide Cyclosporins |
Cyclosporine Campath 1G Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 23, 2013