AMLPhase 2MINI HEMENCT00636909
Nonmyeloablative Allo SCT for the Treatment of Hematologic Disorders
A Phase 2 study testing Cyclophosphamide, fludarabine and cyclosporine in people with AML and ALL, run by Beth Israel Deaconess Medical Center.
Trial summary
The purpose of this study is to provide allogeneic stem cell transplantation to patients who have not traditionally undergone this procedure because of it high incidence of treatment related side effects. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- AML, ALL, CML Chronic Phase, Accelerated Phase, or Blast Crisis
- What is being tested?
- Cyclophosphamide, fludarabine and cyclosporine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jul 1999to Mar 2006
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- AML, ALL,CML Chronic Phase, Accelerated Phase, or Blast Crisis, CLL, MDS, RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA, Aplastic Anemia, Multiple Myeloma, MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET
- Age less than 65 years
- Patients must have a healthy family member who is HLA-identical to the recipient or has 1 antigen mismatch and who is willing to receive a course of G-CSF and undergo 2-4 daily leukaphereses
- Each patient must sign an informed consent and be willing to participate as a research subject after having been advised of the nature and risk of the study prior to entering protocol
- Absence of hematologic or marrow function related diseases that interferes with the collection of sufficient numbers of normal progenitor cells
- Absence of any medical condition that would pose a serious health risk by undergoing peripheral blood stem cell harvest
- Negative HIV, HTLV-1, Hepatitis B surface antigen and Hepatitis C
- The donor must be blood relation. A prospective related donor must be at least genotypically HLA-A, B, DR identical to the patient, but can differ for 1 HLA-locus.
Who cannot join
- Active CNS involvement
- Females who are pregnant or breast feeding
- ECOG performance status > 1. Karnofsky performance status < 80%
- LVEF < 40%
- Active viral, bacterial, or fungal infection
- Patients seropositive for HIV; HTLV -1
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- Patients not providing informed consent
- Patients with known hypersensitivity to E. Coli derived product
- A positive HIv infection or HTLV - 1 test or evidence of active/persistent viral hepatitis infection. Presence of any medical condition that would pose a serious health risk by undergoing peripheral blood stem cell harvest. Donors with known hypersensitivity to E. Coli derived products.
About this study
Official title: Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders
The purpose of this study is to provide allogeneic stem cell transplantation to patients who have not traditionally undergone this procedure because of it high incidence of treatment related side effects. We hope to decrease these side effects by decreasing the chemotherapy dose prior to transplant (non-myeloablative, smaller dose of chemotherapy given so bone marrow is not completely eliminated) and by using donated stem cells to treat cancer of the blood.
- Conditions
- AML, ALL, CML Chronic Phase, Accelerated Phase, or Blast Crisis, CLL, MDS, RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA
- Being tested
- Cyclophosphamide, fludarabine, cyclosporine, methotrexate, G-CSF
- Keywords
- AML, ALL, CML, CLL, MDS, NHL, HODGKIN'S LYMPHOMA, APLASTIC ANEMIA, MULTIPLE MYELOMA, MYELOPROLIFERATIVE DISORDER, ALLOGENEIC, STEM CELL TRANSPLANT, HEMATOLOGIC DISORDERS, CYCLOPHOSPHAMIDE, FLUDARABINE, CYCLOSPORINE, METHOTREXATE, G-CSF, GVHD, ENGRAFTMENT
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase, Blast Crisis, Anemia, Aplastic, Multiple Myeloma, Myeloproliferative Disorders, Hodgkin Disease, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
preparative cytoreduction
fludarabineDrug
preparative cytoreduction
cyclosporineDrug
immunosuppressive therapy
methotrexateDrug
immunosuppressive therapy
G-CSFBiological
foster engraftment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Study treatment arm with G-CSF Receives: Drug: Cyclophosphamide; Drug: fludarabine; Drug: cyclosporine; Drug: methotrexate; Biological: G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
durable engraftment
Measured: 100 days
hematopoeitic reconstitution
Measured: 3 years
evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells
Measured: 3 years
Secondary outcomes (2)
disease free survival and overall survival
Measured: 3 years
incidence of treatment related toxicity and acute and chronic graft versus host disease
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2008 (estimated)
- Study startJul 1999
- Primary completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, David McDermott, Beth Israel Deaconess Medical Center
- Investigators
- David F McDermott, MD, Principal investigator, Beth Israel Deaconess Medical CenterDavid E Avigan, MD, Study director, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636909
- Sponsor's protocol ID
- 2001P002293
- Other IDs
- W-99-0234-FB
- Acronym
- MINI HEME
- Status last verified
- Apr 2017
- First submitted
- 10 Mar 2008
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonmyeloablative Allogeneic Stem Cell Transplant for the Treatment of Hematologic Disorders
- ClinicalTrials.gov ID
- NCT00636909
- Acronym / sponsor ID
- MINI HEME / 2001P002293
- Conditions
- AML, ALL, CML Chronic Phase, Accelerated Phase, or Blast Crisis, CLL, MDS, RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA
- Keywords
- AML, ALL, CML, CLL, MDS, NHL, HODGKIN'S LYMPHOMA, APLASTIC ANEMIA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Jul 1999
- Primary completion
- Mar 2006 (actual)
- First posted
- 17 Mar 2008 (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.
The purpose of this study is to provide allogeneic stem cell transplantation to patients who have not traditionally undergone this procedure because of it high incidence of treatment related side effects. We hope to decrease these side effects by decreasing the chemotherapy dose prior to transplant (non-myeloablative, smaller dose of chemotherapy given so bone marrow is not completely eliminated) and by using donated stem cells to treat cancer of the blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Cyclophosphamide, Drug: fludarabine, Drug: cyclosporine, Drug: methotrexate, Biological: G-CSFStudy treatment arm with G-CSF |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- AML, ALL,CML Chronic Phase, Accelerated Phase, or Blast Crisis, CLL, MDS, RELAPSED NON-HODGKIN'S OR HODGKIN'S LYMPHOMA, Aplastic Anemia, Multiple Myeloma, MYELOPROLIFERATIVE DISORDER (P Vera, CMML, ET
- Age less than 65 years
- Patients must have a healthy family member who is HLA-identical to the recipient or has 1 antigen mismatch and who is willing to receive a course of G-CSF and undergo 2-4 daily leukaphereses
- Each patient must sign an informed consent and be willing to participate as a research subject after having been advised of the nature and risk of the study prior to entering protocol
- Absence of hematologic or marrow function related diseases that interferes with the collection of sufficient numbers of normal progenitor cells
Key exclusion criteria (9 listed)
- Active CNS involvement
- Females who are pregnant or breast feeding
- ECOG performance status > 1. Karnofsky performance status < 80%
- LVEF < 40%
- Active viral, bacterial, or fungal infection
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 |
|---|---|---|
| Cyclophosphamidepreparative cytoreduction | Drug | 1 |
| fludarabinepreparative cytoreduction | Drug | 1 |
| cyclosporineimmunosuppressive therapy | Drug | 1 |
| methotrexateimmunosuppressive therapy | Drug | 1 |
| G-CSFfoster engraftment | Biological | 1 |
Primary outcome
durable engraftment
Time frame: 100 days
hematopoeitic reconstitution
Time frame: 3 years
evaluate the patterns of post-transplant chimerism among lymphoid and antigen presenting cells
Time frame: 3 years
2 secondary outcomes
disease free survival and overall survival
Time frame: 3 years
incidence of treatment related toxicity and acute and chronic graft versus host disease
Time frame: 100 days
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 6 Apr 2017.
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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.
David F McDermott, MD principal investigator
Beth Israel Deaconess Medical Center
David E Avigan, MD study director
Beth Israel Deaconess Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide, fludarabine and cyclosporine in people with AML and ALL, run by Beth Israel Deaconess Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. 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 6 Apr 2017. 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.
What does the primary outcome measure?
durable engraftment (time frame: 100 days). The study lists 3 primary outcomes in all. 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 6 Apr 2017.