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LeukemiaPhase 2NCT00008307

Combination Chemotherapy Followed by Donor Bone Marrow Transplant or Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer or Genetic Disorders

A Phase 2 study testing anti-thymocyte globulin, cyclosporine and fludarabine phosphate in people with Leukemia and Lymphoma, run by Herbert Irving Comprehensive Cancer Center at 1 site in United States.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 drugs, such as fludarabine and melphalan, before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of cancer or abnormal cells. Read more about this study

Who is it for?
Ages 1 year to 80 years
What is being tested?
anti-thymocyte globulin, cyclosporine and fludarabine phosphate
Type of treatment
Surgery or procedure
How many people
52 participants
Where
1 siteUnited States
Study dates
Apr 1998to not given
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 1 year to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Clinically and/or histologically confirmed hematologic malignancy or genetic disorder
  • Chronic myelogenous leukemia
  • Typical blood and marrow morphology
  • Presence of Philadelphia chromosome OR
  • Molecular evidence of bcr/abl rearrangement if Philadelphia chromosome-negative
  • Acute myeloid leukemia, acute lymphocytic leukemia, myelodysplasia, or lymphoma
  • High risk of relapse or progressive disease
  • Typical clinical features and morphology in blood, marrow, lymph node, or other tissue by cytochemistry, immunophenotyping, and/or chromosomal abnormalities
  • Multiple myeloma
  • Typical marrow morphology, radiographic findings, and paraprotein
  • Aplastic anemia
  • Typical marrow and blood findings
  • Genetic disorder including storage disease (e.g., adrenoleukodystrophy), hemoglobinopathies (e.g., thalassemia), or severe immunodeficiency
  • Unwilling to undergo conventional high-dose chemoradiotherapeutic conditioning prior to allogeneic stem cell transplantation OR
  • Presence of other medical disorder which precludes high-dose chemoradiotherapeutic conditioning (e.g., cardiac disease or infection)
  • Syngeneic twin, HLA-identical, or 1 or 2 HLA antigen-mismatched family member or unrelated donor

PATIENT CHARACTERISTICS:

Age:

  • 1 to 80

Performance status:

  • Karnofsky 50-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other serious medical or psychiatric illness that would preclude study compliance
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • Not specified

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Herbert Irving Comprehensive Cancer Center at Columbia University

    New York, New York, 10032

Other trials in United States

About this study

Official title: Non-Ablative Chemotherapeutic Conditioning Before Allogeneic Stem Cell Transplantation

RATIONALE: Giving chemotherapy drugs, such as fludarabine and melphalan, before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of cancer or abnormal 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.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy followed by donor bone marrow transplant or peripheral stem cell transplant works in treating patients with hematologic cancer or genetic disorders.

Read the detailed description

OBJECTIVES:

  • Determine the hematopoietic recovery in patients with hematologic malignancies or genetic disorders treated with fludarabine and melphalan followed by allogeneic or syngeneic bone marrow or peripheral blood stem cell transplantation.
  • Determine the chemotherapeutic toxicity of this regimen in these patients.
  • Determine the relapse and survival of patients treated with this regimen.
  • Determine the incidence of graft-versus-host disease in patients treated with this regimen.

OUTLINE: Patients receive fludarabine IV on days -6 to -2 and melphalan IV on days -3 and -2. Patients with a non-HLA-identical family member may also receive anti-thymocyte globulin on days -4 to -1. Patients undergo allogeneic or syngeneic bone marrow or peripheral blood stem cell transplantation on day 0. Patients receive graft-vs-host disease prophylaxis comprising mycophenolate mofetil twice daily beginning on day -3, methylprednisolone beginning on day 5 and continuing over 8 weeks, and cyclosporine IV or orally beginning on day -3 and continuing until at least 6 months post-transplantation.

Patients are followed at 1, 3, and 6 months, and then at 1 year post-transplantation.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 5-6 years.

Being tested
anti-thymocyte globulin, cyclosporine, fludarabine phosphate, melphalan, methylprednisolone
Keywords
stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, recurrent childhood acute lymphoblastic leukemia, recurrent adult Hodgkin lymphoma, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, stage I childhood lymphoblastic lymphoma, stage II childhood lymphoblastic lymphoma, stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, recurrent childhood lymphoblastic lymphoma
Medical subject headings
Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Hodgkin Disease, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, T-Cell, Cutaneous

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. Hematopoietic recovery

  2. Incidence of graft-versus-host disease

Secondary outcomes (2)

  1. Chemotherapeutic toxicity

  2. Relapse and survival

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 1998

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
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00008307
Sponsor's protocol ID
CDR0000068396
Other IDs
CPMC-IRB-8462, CPMC-IRB-CAMP-25, NCI-G00-1897
Status last verified
Apr 2006
First submitted
6 Jan 2001
Last updated
6 Jan 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anti-thymocyte globulin, cyclosporine and fludarabine phosphate in people with Leukemia and Lymphoma, run by Herbert Irving Comprehensive Cancer Center at 1 site in United States.

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 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Hematopoietic recovery. The study lists 2 primary outcomes in all. 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 NCT00008307.

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 6 Jan 2014.

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