LeukemiaPhase 2NCT00002554
Monoclonal Antibody Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia in Remission or First Relapse
A Phase 2 study testing busulfan, cyclophosphamide and methotrexate in people with Leukemia, run by Fred Hutchinson Cancer Center.
Trial summary
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Monoclonal antibody combined with a radioactive substance and given prior to bone marrow transplantation may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Leukemia
- What is being tested?
- busulfan, cyclophosphamide and methotrexate
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 1993to Dec 1999
- 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 55 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS: Acute myelogenous leukemia in first or second remission or untreated first relapse Documented CD45 expression by leukemic cells required for patients in relapse Phenotyping not required for patients in remission; such patients may have leukemia previously documented to be CD45 negative Circulating blast count less than 10,000 (control with hydroxyurea or similar agent allowed) Genotypically or phenotypically HLA-matched related marrow donor required No donors mismatched for 1 or more HLA antigens No psychologic, physiologic, or medical contraindication to donation No high risk for anesthesia because of age or medical problems No HIV seropositive donors
PATIENT CHARACTERISTICS: Age: 16 to 55 Performance status: Not specified Life expectancy: Greater than 60 days Hematopoietic: Not applicable Hepatic: Bilirubin less than 1.5 mg/dl No risk of developing veno-occlusive disease of the liver (i.e., current evidence of hepatitis as manifested by SGOT greater than 1.5 x ULN) Renal: Creatinine less than 2.0 mg/dl Other: No HIV seropositivity No major infection
PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior radiotherapy to maximally tolerated levels for any normal organ
About this study
Official title: RADIOLABELED BC8 (ANTI-CD45) ANTIBODY COMBINED WITH BUSULFAN AND CYCLOPHOSPHAMIDE AS TREATMENT FOR ACUTE MYELOGENOUS LEUKEMIA IN FIRST OR SECOND REMISSION OR UNTREATED FIRST RELAPSE FOLLOWED BY HLA-IDENTICAL RELATED MARROW TRANSPLANTATION
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Monoclonal antibody combined with a radioactive substance and given prior to bone marrow transplantation may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody given prior to bone marrow transplantation in treating patients with acute myelogenous leukemia.
Read the detailed description
OBJECTIVES: I. Determine the overall and disease-free survival and toxicity associated with busulfan/cyclophosphamide (BU/CTX) plus 131I-labeled BC8 antibody (131I-BC8) followed by an HLA-identical related marrow transplant in patients with acute myelogenous leukemia in first or second remission or untreated first relapse. II. Study factors that may influence the biodistribution of 131I-BC8 in this patient population, including marrow cellularity, the level of antigen expression by leukemic cells (in relapsed patients), and the degree of antigen saturation by antibody. III. Determine the efficacy of BU/CTX in patients in first remission unable to receive radiolabeled antibody, e.g., patients who are HAMA-positive, those not tolerating antibody test infusion, those with unfavorable antibody biodistribution, or those for whom antibody is unavailable.
OUTLINE: Radioimmunotherapy plus 2-Drug Cytoreductive Chemotherapy followed by Bone Marrow Transplantation with, as indicated, CNS Therapy. Iodine-131-labeled Monoclonal Antibody BC8 (anti-CD45), 131I-BC8; plus Busulfan, BU, NSC-750; Cyclophosphamide, CTX, NSC-26271; followed by Allogeneic Bone Marrow, ABM; with, as indicated, Intrathecal Methotrexate, IT MTX, NSC-740.
PROJECTED ACCRUAL: It is anticipated that 30 patients in first remission, 30 patients in untreated first relapse, and 15 patients in second remission will be accrued over 3 years.
- Conditions
- Leukemia
- Being tested
- busulfan, cyclophosphamide, methotrexate, allogeneic bone marrow transplantation, radioimmunotherapy
- Keywords
- recurrent adult acute myeloid leukemia, adult acute myeloid leukemia in remission
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
busulfanDrug
cyclophosphamideDrug
methotrexateDrug
allogeneic bone marrow transplantationProcedure or surgery
radioimmunotherapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2004 (estimated)
- Study startNov 1993
- Primary completionDec 1999
- Study completionDec 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- John Pagel, MD, PhD, Study chair, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002554
- Sponsor's protocol ID
- 832.00
- Other IDs
- CDR0000063421, NCI-V94-0393
- Status last verified
- Mar 2010
- First submitted
- 1 Nov 1999
- Last updated
- 30 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RADIOLABELED BC8 (ANTI-CD45) ANTIBODY COMBINED WITH BUSULFAN AND CYCLOPHOSPHAMIDE AS TREATMENT FOR ACUTE MYELOGENOUS LEUKEMIA IN FIRST OR SECOND REMISSION OR UNTREATED FIRST RELAPSE FOLLOWED BY HLA-IDENTICAL RELATED MARROW TRANSPLANTATION
- ClinicalTrials.gov ID
- NCT00002554
- Acronym / sponsor ID
- 832.00
- Conditions
- Leukemia
- Keywords
- recurrent adult acute myeloid leukemia, adult acute myeloid leukemia in remission
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- Nov 1993
- Primary completion
- Dec 1999 (actual)
- Study completion
- Dec 1999 (actual)
- First posted
- 31 Aug 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: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Monoclonal antibody combined with a radioactive substance and given prior to bone marrow transplantation may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody given prior to bone marrow transplantation in treating patients with acute myelogenous leukemia.
Detailed description
OBJECTIVES: I. Determine the overall and disease-free survival and toxicity associated with busulfan/cyclophosphamide (BU/CTX) plus 131I-labeled BC8 antibody (131I-BC8) followed by an HLA-identical related marrow transplant in patients with acute myelogenous leukemia in first or second remission or untreated first relapse. II. Study factors that may influence the biodistribution of 131I-BC8 in this patient population, including marrow cellularity, the level of antigen expression by leukemic cells (in relapsed patients), and the degree of antigen saturation by antibody. III. Determine the efficacy of BU/CTX in patients in first remission unable to receive radiolabeled antibody, e.g., patients who are HAMA-positive, those not tolerating antibody test infusion, those with unfavorable antibody biodistribution, or those for whom antibody is unavailable.
OUTLINE: Radioimmunotherapy plus 2-Drug Cytoreductive Chemotherapy followed by Bone Marrow Transplantation with, as indicated, CNS Therapy. Iodine-131-labeled Monoclonal Antibody BC8 (anti-CD45), 131I-BC8; plus Busulfan, BU, NSC-750; Cyclophosphamide, CTX, NSC-26271; followed by Allogeneic Bone Marrow, ABM; with, as indicated, Intrathecal Methotrexate, IT MTX, NSC-740.
PROJECTED ACCRUAL: It is anticipated that 30 patients in first remission, 30 patients in untreated first relapse, and 15 patients in second remission will be accrued over 3 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 to 55 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 |
|---|---|---|
| busulfan | Drug | – |
| cyclophosphamide | Drug | – |
| methotrexate | Drug | – |
| allogeneic bone marrow transplantation | Procedure or surgery | – |
| radioimmunotherapy | 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 30 Mar 2010.
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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 Pagel, MD, PhD study chair
Fred Hutchinson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing busulfan, cyclophosphamide and methotrexate in people with Leukemia, run by Fred Hutchinson Cancer Center.
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 30 Mar 2010. 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?
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 30 Mar 2010.