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Status unknownNCT00908180Updated Aug 2, 2013

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

A Phase 2 interventional study of alemtuzumab and donor lymphocytes in Lymphoma, sponsored by Cancer Research UK. Status unknown. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-08-02.

Sponsored by Cancer Research UK · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2009), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
47
Ages
16 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Lymphoma

Keywords

  • recurrent adult Hodgkin lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 47 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Cancer Research UK is the lead sponsor of 83 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
47 participants (estimated)

Interventions

  • Biologicalalemtuzumab
  • Biologicaldonor lymphocytes
  • Drugcarmustine
  • Drugcyclosporine
  • Drugcytarabine
  • Drugetoposide
  • Drugmelphalan
  • Procedureallogeneic hematopoietic stem cell transplantation
06

What researchers measure

Primary outcomes

  1. Progression-free survival at 3 years

Secondary outcomes

  1. Donor engraftment rates, including chimerism at 3 and 6 months

  2. Non-relapse mortality at 100 days, 1 year, and 2 years post-transplant

  3. Incidence of grade II-IV toxicity as assessed by NCI CTCAE v3.0

  4. Incidence, severity, and timing of acute and chronic graft-versus-host disease

  5. Response rates

  6. Relapse rates

  7. Response to donor lymphocyte infusions

  8. Overall survival

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Das-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. PubMed 31869413 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00908180
Lead sponsor
Cancer Research UK
First posted
May 25, 2009
Start date
Jul 2009
Primary completion
Jul 2014 (estimated)
Last update
Aug 2, 2013

Study contacts

Karl Peggs, MD
principal investigator · University College London (UCL) Cancer Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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