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Carmustine, Etoposide, Cytarabine, Melphalan, and Alemtuzumab Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: May 22, 2009
Last updated: August 1, 2013
Last verified: June 2009

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
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival at 3 years

Secondary Outcome Measures:
  • Donor engraftment rates, including chimerism at 3 and 6 months
  • Non-relapse mortality at 100 days, 1 year, and 2 years post-transplant
  • Incidence of grade II-IV toxicity as assessed by NCI CTCAE v3.0
  • Incidence, severity, and timing of acute and chronic graft-versus-host disease
  • Response rates
  • Relapse rates
  • Response to donor lymphocyte infusions
  • Overall survival

Estimated Enrollment: 47
Study Start Date: July 2009
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics
  • No prior high-dose therapy or allograft
  Contacts and Locations
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Please refer to this study by its identifier: NCT00908180

Sponsors and Collaborators
Cancer Research UK
Principal Investigator: Karl Peggs, MD University College London (UCL) Cancer Institute
  More Information Identifier: NCT00908180     History of Changes
Other Study ID Numbers: CRUK-PAIReD
CDR0000640493 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: May 22, 2009
Last Updated: August 1, 2013

Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Etoposide phosphate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on April 28, 2017