Chronic Myeloproliferative DisordersPhase 2NCT00005622
Donor Bone Marrow Transplant in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
A Phase 2 study testing cyclophosphamide and TBI in people with Chronic Myeloproliferative Disorders and Leukemia, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow 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 15 to 50 years
- Conditions the study is for
- Chronic Myeloproliferative Disorders, Leukemia, Multiple Myeloma and Malignant Plasma Cell Neoplasms
- What is being tested?
- cyclophosphamide and TBI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- May 1996to Jul 2009
- 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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of one of the following:
- Acute lymphocytic leukemia (ALL):
- Complete remission (CR) 1 - high risk defined as overt CNS involvement or poor cytogenetics (additions, deletions, translocations, or multiple abnormalities)
- CR2
- Induction failures
- Relapse - patients with at least 10% marrow blasts undergo at least one reinduction attempt
- Acute myelogenous leukemia (AML):
- CR1 - high risk defined as poor cytogenetics (deletions, additions, multiple abnormalities)
- CR2
- Induction failures
- Relapse - patients with at least 10% marrow blasts undergo at least one reinduction attempt
- Chronic myelogenous leukemia (CML):
- Chronic phase (CP) 1
- Accelerated phase/CP2 - patients in blast phase must undergo treatment and achieve a second chronic phase prior to transplant
- Chronic lymphocytic leukemia (CLL):
- Relapse - any stage; must have received no more than 3 prior regimens
- Multiple myeloma:
- At diagnosis - primary refractory
- Relapse (no more than 2) - sensitive disease
- Plasma cell leukemia
- Inability to achieve a complete remission after autologous transplant (no older than 40)
- Myelodysplasia - all subtypes
- Myeloproliferative disorders - patients with poor response to medical therapy or cytogenetic abnormalities
- Severe aplastic anemia (SAA):
- Very SAA - at diagnosis
- SAA - induction therapy
- Donors must be a phenotypic (6 out of 6) match or a one antigen (A or B) mismatch
PATIENT CHARACTERISTICS:
Age:
- 15 to 50
Performance status:
- Karnofsky 80-100%
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT and SGPT no greater than 3 times normal
- PT/PTT normal
Renal:
- Creatinine no greater than 2.0 mg/dL
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- Left ventricular ejection fraction at least 45%
- No myocardial infarction within past 6 months
- No uncontrolled arrhythmias
Pulmonary:
- FEV1 at least 50%
- DLCO at least 50% predicted
Other:
- No active serious infection
- HIV negative
- Not pregnant or nursing
- No uncontrolled diabetes mellitus or thyroid disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Allogeneic Bone Marrow Transplantation Using Closely Matched Related and Unrelated Donors
RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related or unrelated donor, that closely matches the patient's blood, are infused into the patient they may help the patient's bone marrow to make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in treating patients with leukemia, lymphoma, or nonmalignant hematologic disorders.
Read the detailed description
OBJECTIVES:
- Determine the survival of allogeneic bone marrow transplantation using closely matched related and unrelated donors in patients with malignant or nonmalignant hematological disorders.
- Determine the incidence and severity of acute and chronic graft versus host disease with this treatment regimen in these patients.
- Determine the relapse rates with this treatment regimen in those patients with malignant disorders.
- Determine the incidence and severity of infectious complications associated with this treatment regimen in these patients.
OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days -6 and -5, total body radiotherapy on days -3 through 0, and allogeneic bone marrow transplantation on day 0.
Patients with acute lymphocytic leukemia (ALL) receive intrathecal methotrexate at the beginning of the study. If CNS involvement is documented, patients receive a second dose of methotrexate 48 hours later followed by oral leucovorin calcium every 6 hours for 4 doses. Patients with ALL and/or CNS involvement receive intrathecal methotrexate every other week for 12 weeks after transplant.
Patients with prior CNS involvement receive radiotherapy for 2.5 weeks prior to transplant. Patients with ALL receive total body radiotherapy for 5 consecutive days prior to transplant.
Patients are followed once a week for 3 months, and then monthly for 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 6 years.
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Multiple Myeloma and Malignant Plasma Cell Neoplasms, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- Being tested
- cyclophosphamide, TBI
- Keywords
- recurrent childhood acute lymphoblastic leukemia, refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, recurrent childhood acute myeloid leukemia, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, refractory chronic lymphocytic leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, blastic 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
- Medical subject headings
- Myeloproliferative Disorders, Leukemia, Multiple Myeloma, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
Cyclophosphamide is administered at a dose of 60 mg/kg on each of two successive days (Days -6 and -5)
TBIRadiation
FTBI is performed on day -3 through day 0 The total dose of radiation is 1,320 cGy.
| Study group | Role | What they receive |
|---|---|---|
| Cy/TBI | Other | cyclophosphamide and total body irradiation (TBI) Receives: Drug: cyclophosphamide; Radiation: TBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
event free survival (EFS)
EFS determined by the Kaplan-Meier product limit method
Measured: five year post transplant
Secondary outcomes (1)
Incidence of graft versus host disease
incidence and severity of acute and chronic GVHD
Measured: five years post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMay 1996
- Primary completionSep 2005
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloproliferative DisordersStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Teresa Field, MD, PhD, Study chair, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005622
- Sponsor's protocol ID
- MCC-11282
- Other IDs
- IRB-4189, NCI-G00-1755
- Status last verified
- Oct 2012
- First submitted
- 2 May 2000
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Bone Marrow Transplantation Using Closely Matched Related and Unrelated Donors
- ClinicalTrials.gov ID
- NCT00005622
- Acronym / sponsor ID
- MCC-11282
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Multiple Myeloma and Malignant Plasma Cell Neoplasms, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- Keywords
- recurrent childhood acute lymphoblastic leukemia, refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1996
- Primary completion
- Sep 2005 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 27 Jan 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: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related or unrelated donor, that closely matches the patient's blood, are infused into the patient they may help the patient's bone marrow to make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in treating patients with leukemia, lymphoma, or nonmalignant hematologic disorders.
Detailed description
OBJECTIVES:
- Determine the survival of allogeneic bone marrow transplantation using closely matched related and unrelated donors in patients with malignant or nonmalignant hematological disorders.
- Determine the incidence and severity of acute and chronic graft versus host disease with this treatment regimen in these patients.
- Determine the relapse rates with this treatment regimen in those patients with malignant disorders.
- Determine the incidence and severity of infectious complications associated with this treatment regimen in these patients.
OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days -6 and -5, total body radiotherapy on days -3 through 0, and allogeneic bone marrow transplantation on day 0.
Patients with acute lymphocytic leukemia (ALL) receive intrathecal methotrexate at the beginning of the study. If CNS involvement is documented, patients receive a second dose of methotrexate 48 hours later followed by oral leucovorin calcium every 6 hours for 4 doses. Patients with ALL and/or CNS involvement receive intrathecal methotrexate every other week for 12 weeks after transplant.
Patients with prior CNS involvement receive radiotherapy for 2.5 weeks prior to transplant. Patients with ALL receive total body radiotherapy for 5 consecutive days prior to transplant.
Patients are followed once a week for 3 months, and then monthly for 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 6 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cy/TBI | Other | Drug: cyclophosphamide, Radiation: TBIcyclophosphamide and total body irradiation (TBI) |
Who may qualify
- Ages
- 15 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 |
|---|---|---|
| cyclophosphamideCyclophosphamide is administered at a dose of 60 mg/kg on each of two successive days (Days -6 and -5) | Drug | Cy/TBI |
| TBIFTBI is performed on day -3 through day 0 The total dose of radiation is 1,320 cGy. | Radiation | Cy/TBI |
Primary outcome
event free survival (EFS)
Time frame: five year post transplant
EFS determined by the Kaplan-Meier product limit method
1 secondary outcome
Incidence of graft versus host disease
Time frame: five years post transplant
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 25 Oct 2012.
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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.
Teresa Field, MD, PhD study chair
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cyclophosphamide and TBI in people with Chronic Myeloproliferative Disorders and Leukemia, run by H. Lee Moffitt Cancer Center and Research Institute 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: finished, as of the sponsor's last update on 25 Oct 2012. 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?
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.
What does the primary outcome measure?
event free survival (EFS) (time frame: five year post transplant). It is what the study was designed to measure, not a finding.
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 25 Oct 2012.