LeukemiaNCT00038779
Blood Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States
A study testing Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation in people with Leukemia and Non Hodgkin's Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to assess early treatment failure within 100 days and to assess the effect of this regimen on engraftment, GVHD, immune recovery, relapse of malignancy and survival. Read more about this study
- Who is it for?
- Ages Up to 49 years
- Conditions the study is for
- Leukemia, Non Hodgkin's Lymphoma, Aplastic Anemia
- What is being tested?
- Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 1996to 20 Sep 2004
- Phase
- Interventional
- 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 49 years
- All sexes
- No healthy volunteers
- Child, Adult
- Patients with acute leukemia, lymphoma that failed to respond or relapsed after chemotherapy or CML beyond first chronic phase.
- Patients with aplastic anemia or myelodysplasia which failed to respond to primary therapy are eligible.
- Patients with low grade lymphoma or CLL will only be eligible if they failed two chemotherapy regimens and have stage IV disease.
- Patients must be <age 50 with a related haploidentical donor (phenotypically one, two or three HLA A, B and DR antigen mismatched) donor.
- Patients should have adequate hepatic and renal function with a bilirubin of less than or equal to 1.5mg%, SGPT less than or equal to 3x the upper limits of normal, and creatine less than or equal to 1.5mg%.
- Patients with serious intercurrent medical illness are not eligible.
- Patients and their donors must provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States
The purpose of this study is to assess early treatment failure within 100 days and to assess the effect of this regimen on engraftment, GVHD, immune recovery, relapse of malignancy and survival.
- Conditions
- Leukemia, Non Hodgkin's Lymphoma, Aplastic Anemia
- Being tested
- Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation
- Keywords
- Lymphoma, CML, CLL, AML, ALL, MDS, AA
- Medical subject headings
- Leukemia, Lymphoma, Non-Hodgkin, Anemia, Aplastic, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell TransplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Megadose T cell depleted | Experimental | Not described Receives: Procedure: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2002 (estimated)
- Study start14 Aug 1996
- Primary completion20 Sep 2004
- Study completion20 Sep 2004
Why it stopped: Lack of Accrual
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 M.D. Anderson 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038779
- Sponsor's protocol ID
- DM96-122
- Status last verified
- Oct 2018
- First submitted
- 5 Jun 2002
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States
- ClinicalTrials.gov ID
- NCT00038779
- Acronym / sponsor ID
- DM96-122
- Conditions
- Leukemia, Non Hodgkin's Lymphoma, Aplastic Anemia
- Keywords
- Lymphoma, CML, CLL, AML, ALL, MDS, AA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 14 Aug 1996 (actual)
- Primary completion
- 20 Sep 2004 (actual)
- Study completion
- 20 Sep 2004 (actual)
- First posted
- 7 Jun 2002 (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 assess early treatment failure within 100 days and to assess the effect of this regimen on engraftment, GVHD, immune recovery, relapse of malignancy and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Megadose T cell depleted | Experimental | Procedure: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation |
Who may qualify
- Ages
- Up to 49 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 |
|---|---|---|
| Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation | Procedure or surgery | Megadose T cell depleted |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Lack of Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation in people with Leukemia and Non Hodgkin's Lymphoma, run by M.D. Anderson Cancer Center 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: stopped early, as of the sponsor's last update on 30 Oct 2018. 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.
Are results available for this study?
The study was stopped early (reason given: Lack of Accrual). Results are not available in the source record.
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 Oct 2018.