Graft Versus Host DiseasePhase 3NCT00006451
Bone Marrow Transplantation in Treating Patients With Leukemia
A Phase 3 study testing anti-thymocyte globulin, cyclophosphamide and cyclosporine in people with Graft Versus Host Disease and Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells. PURPOSE: Randomized phase II/III trial to determine the effectiveness of bone marrow transplantation in treating patients who have leukemia. Read more about this study
- Who is it for?
- Ages Up to 45 years
- Conditions the study is for
- Graft Versus Host Disease, Leukemia, Lymphoma
- What is being tested?
- anti-thymocyte globulin, cyclophosphamide and cyclosporine
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1996to Nov 2000
- Phase
- Phase 3
- 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 Up to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS: Acute myelocytic leukemia with or without history of myelodysplastic syndrome Not in first complete remission (i.e., greater than 5% blasts in marrow) with t(8;21), t(15;17), or 16q abnormality unless failure on first-line induction therapy Acute lymphocytic leukemia (ALL) in one of the following categories: In second or third complete remission (CR) High-risk ALL in first CR, with high risk defined as: Hypodiploidy OR pseudodiploidy with t(9;22), t(4;11), or t(8;14) Failure to achieve CR after 4 weeks of induction therapy Elevated WBC at presentation, i.e.: Greater than 100,000 in patients aged 6 to 12 months Greater than 200,000 in patients aged 1 to 20 years Greater than 20,000 in patients aged 21 to 44 years Chronic myelogenous leukemia not in blast crisis (i.e., no greater than 30% promyelocytes plus blasts in bone marrow) Stage IV lymphoblastic lymphoma Undifferentiated or biphenotypic leukemia Unrelated donor available Patients aged 35 and younger: HLA-A, and -B serologic identity and HLA-DRB1 identity by high-resolution DNA typing OR Single HLA-A or -B serologic mismatch with DRB1 identity by high-resolution DNA typing OR HLA-A and -B serologic identity with single DRB1 mismatch by high- or low- resolution DNA typing Patients aged 36 to 44: HLA-A and -B serologic identity and HLA-DRB1 identity by high-resolution DNA typing The following exclude: Relapse 12 months after discontinuing therapy in patients aged 1 to 10 years who are in second remission Active central nervous system or leukemic skin involvement Requirement for additional mediastinal irradiation
PATIENT CHARACTERISTICS: Age: Under 46 Performance status: Karnofsky 70-100% Lansky 50-100% Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 2.5 mg/dL AST less than 3 times normal Renal: Creatinine normal OR Creatinine clearance greater than 60 mL/min Cardiovascular: Asymptomatic OR Resting LVEF greater than 40% and improves with exercise Pulmonary: Asymptomatic OR DLCO greater than 45% of predicted (corrected for hemoglobin) Other: HIV negative No uncontrolled viral, bacterial, or fungal infection Not pregnant or nursing
PRIOR CONCURRENT THERAPY: No prior bone marrow transplantation No prior radiotherapy that precludes total body irradiation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
About this study
Official title: T-cell Depletion In Unrelated Donor Marrow Transplantation
RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.
PURPOSE: Randomized phase II/III trial to determine the effectiveness of bone marrow transplantation in treating patients who have leukemia.
Read the detailed description
OBJECTIVES: I. Compare unrelated donor bone marrow transplantation using T-cell-depleted marrow versus unmodified marrow in adults and children with leukemia. II. Evaluate 2-year leukemia-free survival, primary and secondary graft failure, graft-versus-host disease, infection, and relapse in these patients. III. Assess the quality of life associated with T-cell-depleted versus unmodified, unrelated donor transplantation.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. Patients receive myeloablative therapy according to diagnosis: those with acute lymphocytic leukemia and lymphoblastic lymphoma are treated with total body irradiation (TBI), with a testicular and chest wall boost as appropriate, followed by cyclophosphamide (CTX); patients with undifferentiated or biphenotypic leukemia or with acute or chronic myelocytic leukemia are treated with CTX followed by TBI. Patients are then randomly assigned to receive non-T-cell-depleted, unrelated marrow versus T-cell-depleted, unrelated marrow. The modified marrow is depleted of T-lymphocytes by counterflow elutriation and positively selected for CD34 cells. Graft-versus-host disease (GVHD) prophylaxis with cyclosporine and methotrexate is given to the unmodified marrow group. Patients who receive modified marrow are given antithymocyte globulin (or methylprednisolone) for graft rejection prophylaxis before transplantation and cyclosporine and methylprednisolone for GVHD prophylaxis after transplantation.
- Conditions
- Graft Versus Host Disease, Leukemia, Lymphoma
- Being tested
- anti-thymocyte globulin, cyclophosphamide, cyclosporine, methotrexate, methylprednisolone
- Keywords
- recurrent childhood acute lymphoblastic leukemia, stage IV childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission, childhood acute lymphoblastic leukemia in remission, acute undifferentiated leukemia, stage IV adult lymphoblastic lymphoma, graft versus host disease
- Medical subject headings
- Graft vs Host Disease, Leukemia, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myeloid, Accelerated Phase, Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-thymocyte globulinDrug
cyclophosphamideDrug
cyclosporineDrug
methotrexateDrug
allogeneic bone marrow transplantationProcedure or surgery
in vitro-treated bone marrow transplantationProcedure or surgery
radiation therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2004 (estimated)
- Study startApr 1996
- Primary completionNov 2000
- Study completionNov 2000
Why it stopped: Terminated (due to no accrual)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Investigators
- John E. Wagner, MD, Study chair, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006451
- Sponsor's protocol ID
- 1996LS142
- Other IDs
- UMN-MT-9506
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2000
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-cell Depletion In Unrelated Donor Marrow Transplantation
- ClinicalTrials.gov ID
- NCT00006451
- Acronym / sponsor ID
- 1996LS142
- Conditions
- Graft Versus Host Disease, Leukemia, Lymphoma
- Keywords
- recurrent childhood acute lymphoblastic leukemia, stage IV childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated (due to no accrual)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Apr 1996
- Primary completion
- Nov 2000 (actual)
- Study completion
- Nov 2000 (actual)
- First posted
- 9 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.
PURPOSE: Randomized phase II/III trial to determine the effectiveness of bone marrow transplantation in treating patients who have leukemia.
Detailed description
OBJECTIVES: I. Compare unrelated donor bone marrow transplantation using T-cell-depleted marrow versus unmodified marrow in adults and children with leukemia. II. Evaluate 2-year leukemia-free survival, primary and secondary graft failure, graft-versus-host disease, infection, and relapse in these patients. III. Assess the quality of life associated with T-cell-depleted versus unmodified, unrelated donor transplantation.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. Patients receive myeloablative therapy according to diagnosis: those with acute lymphocytic leukemia and lymphoblastic lymphoma are treated with total body irradiation (TBI), with a testicular and chest wall boost as appropriate, followed by cyclophosphamide (CTX); patients with undifferentiated or biphenotypic leukemia or with acute or chronic myelocytic leukemia are treated with CTX followed by TBI. Patients are then randomly assigned to receive non-T-cell-depleted, unrelated marrow versus T-cell-depleted, unrelated marrow. The modified marrow is depleted of T-lymphocytes by counterflow elutriation and positively selected for CD34 cells. Graft-versus-host disease (GVHD) prophylaxis with cyclosporine and methotrexate is given to the unmodified marrow group. Patients who receive modified marrow are given antithymocyte globulin (or methylprednisolone) for graft rejection prophylaxis before transplantation and cyclosporine and methylprednisolone for GVHD prophylaxis after transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- Up to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-thymocyte globulin | Drug | – |
| cyclophosphamide | Drug | – |
| cyclosporine | Drug | – |
| methotrexate | Drug | – |
| methylprednisolone | Drug | – |
| allogeneic bone marrow transplantation | Procedure or surgery | – |
| in vitro-treated bone marrow transplantation | Procedure or surgery | – |
| radiation therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John E. Wagner, MD study chair
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing anti-thymocyte globulin, cyclophosphamide and cyclosporine in people with Graft Versus Host Disease and Leukemia, run by Masonic Cancer Center, University of Minnesota 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: withdrawn, as of the sponsor's last update on 3 Jan 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
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 3 Jan 2020.