Graft Versus Host DiseasePhase 2/3NCT00004255
Treatment of Bone Marrow to Prevent Graft-Versus-Host Disease in Patients With Acute or Chronic Leukemia Undergoing Bone Marrow Transplantation
A Phase 2/3 study testing anti-thymocyte globulin, filgrastim and cyclophosphamide in people with Graft Versus Host Disease and Leukemia, run by Chimeric Therapies at 15 sites in United States.
Trial summary
RATIONALE: Bone marrow that has been treated to remove certain white blood cells may reduce the chance of developing graft-versus-host disease following bone marrow transplantation. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Graft Versus Host Disease, Leukemia, Myelodysplastic Syndromes
- What is being tested?
- anti-thymocyte globulin, filgrastim and cyclophosphamide
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 15 sitesUnited States
- Study dates
- Mar 2000to May 2003
- Phase
- Phase 2/3
- 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 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Diagnosis of one of the following:
- Acute myelogenous leukemia (AML) or acute lymphocytic leukemia (ALL) in first early relapse, second remission, or subsequent remission
- AML in first complete remission with one of the following adverse features:
- Antecedent hematologic disorder such as myelodysplasia
- AML resulting from prior chemotherapy or radiotherapy
- More than 1 course of induction chemotherapy to achieve remission or adverse cytogenetics such as Philadelphia chromosome 9:22, +8, +11; abnormal 12p; or deletions of chromosomes 5, 7, or 20 (3:3)
- ALL in first complete remission with poor risk cytogenetics such as
- Philadelphia chromosome 9:22, 8:14, or 4:11 OR
- WBC greater than 100,000/mm3 OR
- Time to achieve complete remission more than 4 weeks
- Chronic myelogenous leukemia in chronic or accelerated phase
- Myelodysplastic syndromes
- Refractory anemia with excess blasts (RAEB) OR
- RAEB in transformation
- Unrelated bone marrow donor available
- If matched at 6 of 6 HLA-A, -B, and -DR loci, patient must be 12 to 50 years
- If matched at 5 of 6 loci, patient must be 12 to 35 years
- No matched sibling donor available
- No uncontrolled CNS leukemia
PATIENT CHARACTERISTICS:
Age:
- See Disease Characteristics
- 12 to 50
Performance status:
- Karnofsky 70-100%
Life expectancy:
- At least 12 weeks
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Bilirubin less than 2.5 times upper limit of normal (ULN)
- SGOT or SGPT less than 2.5 times ULN
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- LVEF greater than 50% without medication
Pulmonary:
- DLCO and FVC at least 50% predicted
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other serious medical illness
- No uncontrolled diabetes mellitus
- No uncontrolled and/or active infection
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 3 weeks since prior immunotherapy and recovered
- At least 1 year since prior autologous transplantation
- No prior allogeneic transplantation
Chemotherapy:
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy (except hydroxyurea) and recovered
Endocrine therapy:
- At least 3 weeks since prior hormonal therapy and recovered
Radiotherapy:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
- No prior radiotherapy at doses that would preclude study
Surgery:
- Not specified
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Presbyterian-St Luke's Medical Center
Denver, Colorado, 80218
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-100277
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 46202
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
Oregon Cancer Center
Portland, Oregon, 97201-3098
Massey Cancer Center
Richmond, Virginia, 23298-0037
University of Rochester Cancer Center
Rochester, New York, 14642
South Texas Cancer Institute
San Antonio, Texas, 78229
New York Medical College
Valhalla, New York, 10595
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Multi-Center, Open Label, Randomized, Active Controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Processed Unrelated Bone Marrow in Patients With Acute or Chronic Leukemia
RATIONALE: Bone marrow that has been treated to remove certain white blood cells may reduce the chance of developing graft-versus-host disease following bone marrow transplantation.
PURPOSE: Randomized phase II/III trial to compare the effectiveness of treated bone marrow with that of untreated bone marrow in preventing graft-versus-host disease in patients with acute or chronic leukemia who are undergoing bone marrow transplantation.
Read the detailed description
OBJECTIVES:
- Compare the efficacy of processed (cell depleted) vs unprocessed (conventional) unrelated bone marrow transplantation in reducing grade III/IV acute graft vs host disease (GVHD) in patients with acute or chronic leukemia or myelodysplastic syndromes.
- Compare the safety of these regimens in these patients.
- Compare the disease-free survival rate at 100 days and at 6 months in patients treated with these regimens.
- Compare the time to engraftment and percent engraftment in patients treated with these regimens.
- Compare the reduction rate of grade II or greater acute and chronic GVHD in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to degree of HLA matching and disease (chronic vs acute). Acute myelogenous leukemia patients are further stratified according to prior myelodysplastic syndromes (yes vs no). Patients are randomized to one of two bone marrow transplantation arms.
All patients receive a conditioning regimen comprising fludarabine IV on day -6, cyclophosphamide IV on days -5 and -4, anti-thymocyte globulin IV on days -4 and -2, and total body irradiation on days -3 to 0. Patients also receive methylprednisolone IV every 12 hours for 4 doses on days -2 to 0. Tacrolimus IV is administered continuously on day -1 and continues either orally or IV for 6 months. Bone marrow is infused on day 0. Filgrastim (G-CSF) is administered subcutaneously from day 0 until blood counts recover.
- Arm I: Patients receive allogeneic bone marrow that has been processed to produce a mononuclear cell preparation.
- Arm II: Patients receive unprocessed allogeneic bone marrow. Patients are followed weekly for 100 days and then at 6 months.
PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study within 17 months.
- Being tested
- anti-thymocyte globulin, filgrastim, cyclophosphamide, fludarabine phosphate, methylprednisolone
- Keywords
- recurrent childhood acute lymphoblastic leukemia, 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 myeloid leukemia in remission, adult acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, childhood acute lymphoblastic leukemia in remission, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, graft versus host disease, childhood myelodysplastic syndromes
- Medical subject headings
- Graft vs Host Disease, Leukemia, Myelodysplastic Syndromes, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myeloid, Accelerated Phase, Anemia, Refractory, with Excess of Blasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-thymocyte globulinBiological
filgrastimBiological
cyclophosphamideDrug
tacrolimusDrug
allogeneic bone marrow transplantationProcedure or surgery
in vitro-treated bone marrow transplantationProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2003 (estimated)
- Study startMar 2000
- Study completionMay 2003
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Chimeric Therapies
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James N. Lowder, MD, Study chair, Chimeric Therapies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004255
- Sponsor's protocol ID
- CHIMERIC-HM01
- Other IDs
- CDR0000067502, WSU-10-02-99-M01-FB
- Status last verified
- Feb 2002
- First submitted
- 28 Jan 2000
- Last updated
- 10 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open Label, Randomized, Active Controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Processed Unrelated Bone Marrow in Patients With Acute or Chronic Leukemia
- ClinicalTrials.gov ID
- NCT00004255
- Acronym / sponsor ID
- CHIMERIC-HM01
- Keywords
- recurrent childhood acute lymphoblastic leukemia, 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 myeloid leukemia in remission, adult acute lymphoblastic leukemia in remission
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Chimeric TherapiesIndustry (pharma, biotech, devices)
- Study start
- Mar 2000
- Study completion
- May 2003 (actual)
- First posted
- 9 May 2003 (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 that has been treated to remove certain white blood cells may reduce the chance of developing graft-versus-host disease following bone marrow transplantation.
PURPOSE: Randomized phase II/III trial to compare the effectiveness of treated bone marrow with that of untreated bone marrow in preventing graft-versus-host disease in patients with acute or chronic leukemia who are undergoing bone marrow transplantation.
Detailed description
OBJECTIVES:
- Compare the efficacy of processed (cell depleted) vs unprocessed (conventional) unrelated bone marrow transplantation in reducing grade III/IV acute graft vs host disease (GVHD) in patients with acute or chronic leukemia or myelodysplastic syndromes.
- Compare the safety of these regimens in these patients.
- Compare the disease-free survival rate at 100 days and at 6 months in patients treated with these regimens.
- Compare the time to engraftment and percent engraftment in patients treated with these regimens.
- Compare the reduction rate of grade II or greater acute and chronic GVHD in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to degree of HLA matching and disease (chronic vs acute). Acute myelogenous leukemia patients are further stratified according to prior myelodysplastic syndromes (yes vs no). Patients are randomized to one of two bone marrow transplantation arms.
All patients receive a conditioning regimen comprising fludarabine IV on day -6, cyclophosphamide IV on days -5 and -4, anti-thymocyte globulin IV on days -4 and -2, and total body irradiation on days -3 to 0. Patients also receive methylprednisolone IV every 12 hours for 4 doses on days -2 to 0. Tacrolimus IV is administered continuously on day -1 and continues either orally or IV for 6 months. Bone marrow is infused on day 0. Filgrastim (G-CSF) is administered subcutaneously from day 0 until blood counts recover.
- Arm I: Patients receive allogeneic bone marrow that has been processed to produce a mononuclear cell preparation.
- Arm II: Patients receive unprocessed allogeneic bone marrow. Patients are followed weekly for 100 days and then at 6 months.
PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study within 17 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 50 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 | Biological | – |
| filgrastim | Biological | – |
| cyclophosphamide | Drug | – |
| fludarabine phosphate | Drug | – |
| methylprednisolone | Drug | – |
| tacrolimus | Drug | – |
| allogeneic bone marrow transplantation | Procedure or surgery | – |
| in vitro-treated bone marrow transplantation | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
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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.
James N. Lowder, MD study chair
Chimeric Therapies
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing anti-thymocyte globulin, filgrastim and cyclophosphamide in people with Graft Versus Host Disease and Leukemia, run by Chimeric Therapies at 15 sites 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: finished, as of the sponsor's last update on 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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 combined 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 10 Jul 2013.