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AzTrials

LymphomaPhase 2NCT00907036

Fludarabine Phosphate, Melphalan, and Alemtuzumab Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed Hodgkin Lymphoma

A Phase 2 study testing alemtuzumab, donor lymphocytes and cyclosporine in people with Lymphoma, run by Cancer Research UK.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Read more about this study

Who is it for?
Ages 16 to 65 years
Conditions the study is for
Lymphoma
What is being tested?
alemtuzumab, donor lymphocytes and cyclosporine
Type of treatment
Surgery or procedure
How many people
49 participants
Where
No sites listed yet
Study dates
Jul 2009to Jul 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of Hodgkin lymphoma, meeting all of the following criteria:
  • Achieved partial or complete remission (using standard criteria) after salvage chemotherapy
  • Relapsed after first remission with residual fludeoxyglucose F 18-avid lesions
  • Available HLA-matched sibling donor

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Creatinine clearance ≥ 50 mL/min (measured by EDTA clearance or 24-hour urine collection)
  • 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 months (or 3 months for women) after completion of study therapy
  • No other malignancy within the past 5 years except for nonmelanoma skin tumors or stage 0 (in situ) cervical carcinoma
  • No HIV positivity
  • No symptomatic respiratory compromise
  • No concurrent serious medical condition that would preclude transplantation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior high-dose therapy or allograft

About this study

Official title: A Phase II Study of Reduced Intensity Sibling Allogeneic Transplantation for Relapsed, Chemosensitive, PET-positive Hodgkin Lymphoma

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, 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 fludarabine phosphate, melphalan, and alemtuzumab followed by donor stem cell transplant in treating patients with relapsed Hodgkin lymphoma.

Read the detailed description

OBJECTIVES:

  • To document the toxicity, feasibility, and survival after reduced-intensity conditioning followed by allogeneic hematopoietic stem cell transplantation from a matched sibling donor in patients with relapsed, chemosensitive Hodgkin lymphoma.

OUTLINE: This is a multicenter study.

  • Reduced-intensity conditioning: Patients receive fludarabine phosphate IV on days -7 to -3, melphalan IV over 30 minutes on day -2, and alemtuzumab IV on day -1.
  • Transplantation: Patients undergo donor stem cell infusion on day 0.
  • Graft-vs-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV or orally on days -1 to 60, followed by a taper until 3 months post-transplantation, in the absence of GVHD.
  • Donor-lymphocyte infusion (DLI): DLI is used for the eradication of mixed chimerism and for the management of residual or relapsed disease. If necessary, patients undergo DLI every 3 months until the desired endpoint is achieved or GVHD develops.

After completion of study therapy, patients are followed up every 3 months for 3 years.

This study is peer reviewed and funded or endorsed by Cancer Research UK.

Conditions
Lymphoma
Being tested
alemtuzumab, donor lymphocytes, cyclosporine, fludarabine phosphate, melphalan
Keywords
recurrent adult Hodgkin lymphoma
Medical subject headings
Lymphoma, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-year progression-free survival

Secondary outcomes (8)

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

  2. Non-relapse mortality at 100 days and at 1 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 graft-vs-host disease

  5. Response rates

  6. Relapse rates

  7. Response to donor lymphocyte infusions

  8. Overall survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJul 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00907036
Sponsor's protocol ID
CRUK-ReACH
Other IDs
CDR0000640500, EUDRACT-2008-004956-60, EU-20928, UCL/08/0122
Status last verified
Jun 2009
First submitted
21 May 2009
Last updated
2 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing alemtuzumab, donor lymphocytes and cyclosporine in people with Lymphoma, run by Cancer Research UK.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year progression-free survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00907036.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.

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