Acute Lymphoblastic LeukemiaPhase 2/3NCT01015261
Allogenic Bone Marrow Transplantation (BMT) Compare With Cytoreduction and Chemotherapy in Acute Lymphoblastic Leukemia (ALL) Patients
A Phase 2/3 study testing Bone Marrow Transplantation and Chemotherapy in people with Acute Lymphoblastic Leukemia, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Patients with newly diagnosed Acute lymphoblastic leukemia after providing consent, will be screened for eligibility. Eligible patients will be treated with Vincristine (1 mg/m2 at Day 1 and Day 8), Dexamethasone 24 mg/d day 1-15 and IT at Days 1, 4, 8 and 12. At day 14 patients will be randomized in two group. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Bone Marrow Transplantation and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Oct 2008to Sep 2010
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnose of Acute lymphoblastic leukemia
- Age between 16 to 50 year
- New case of ALL
Who cannot join
- Primary CNS involvement
- Primary Testis involvement
- Previously treated
Trial locations and contacts
1 site in 1 country.
Iran1 site
Hematology-Oncology & SCT Research Center
Tehran, Tehran Province, 14114
About this study
Official title: Comparison of Efficacy of Allogenic Bone Marrow Transplantation With Cytoreduction and Chemotherapy in ALL Patients
Patients with newly diagnosed Acute lymphoblastic leukemia after providing consent, will be screened for eligibility. Eligible patients will be treated with Vincristine (1 mg/m2 at Day 1 and Day 8), Dexamethasone 24 mg/d day 1-15 and IT at Days 1, 4, 8 and 12. At day 14 patients will be randomized in two group. BMT group who have donor and Chemotherapy group who don't have suitable donor. BMT group treated with allogenic Bone Marrow Transplantation and Chemotherapy treated with Cyclophosphamide at day 15, Daunorubicin at day 15-18, Vincristine at day 15 and 22 and Dexamethasone at day 12-28 followed by standard chemotherapy. In BMT group patients will be received CNS radiotherapy at +100 day after transplantation.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Bone Marrow Transplantation, Chemotherapy
- Keywords
- ALL, BMT, Chemotherapy, Allogenic
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow TransplantationProcedure or surgery
Allogenic Bone Marrow Transplantation
ChemotherapyProcedure or surgery
- Cyclophosphamide 1200 mg/m2 D15
- Daunorubicin 45 mg/m2 D15-D18
- Vincristine 1 mg/m2 D15, D22
- Dexamethasone 24 mg/d D12-D28
| Study group | Role | What they receive |
|---|---|---|
| Bone Marrow Transplantation | Experimental | Not described Receives: Procedure: Bone Marrow Transplantation |
| Chemotherapy | Active comparator | Not described Receives: Procedure: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient
Measured: 1 year
Secondary outcomes (2)
Overall Survival after BMT compare with chemotherapy.
Measured: 1 year
Disease Free Survival after BMT compare with chemotherapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startOct 2008
- Primary completionMar 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Ardeshir Ghavamzadeh, MD, Study chair, Hematology-Oncology and SCT Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015261
- Sponsor's protocol ID
- HORCSCT-0903
- Status last verified
- Nov 2010
- First submitted
- 17 Nov 2009
- Last updated
- 22 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Allogenic Bone Marrow Transplantation With Cytoreduction and Chemotherapy in ALL Patients
- ClinicalTrials.gov ID
- NCT01015261
- Acronym / sponsor ID
- HORCSCT-0903
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- ALL, BMT, Chemotherapy, Allogenic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 18 Nov 2009 (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.
Patients with newly diagnosed Acute lymphoblastic leukemia after providing consent, will be screened for eligibility. Eligible patients will be treated with Vincristine (1 mg/m2 at Day 1 and Day 8), Dexamethasone 24 mg/d day 1-15 and IT at Days 1, 4, 8 and 12. At day 14 patients will be randomized in two group. BMT group who have donor and Chemotherapy group who don't have suitable donor. BMT group treated with allogenic Bone Marrow Transplantation and Chemotherapy treated with Cyclophosphamide at day 15, Daunorubicin at day 15-18, Vincristine at day 15 and 22 and Dexamethasone at day 12-28 followed by standard chemotherapy. In BMT group patients will be received CNS radiotherapy at +100 day after transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone Marrow Transplantation | Experimental | Procedure: Bone Marrow Transplantation |
| Chemotherapy | Active comparator | Procedure: Chemotherapy |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnose of Acute lymphoblastic leukemia
- Age between 16 to 50 year
- New case of ALL
Key exclusion criteria (3 listed)
- Primary CNS involvement
- Primary Testis involvement
- Previously treated
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 |
|---|---|---|
| Bone Marrow TransplantationAllogenic Bone Marrow Transplantation | Procedure or surgery | Bone Marrow Transplantation |
| Chemotherapy1. Cyclophosphamide 1200 mg/m2 D15 2. Daunorubicin 45 mg/m2 D15-D18 3. Vincristine 1 mg/m2 D15, D22 4. Dexamethasone 24 mg/d D12-D28 | Procedure or surgery | Chemotherapy |
Primary outcome
Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient
Time frame: 1 year
2 secondary outcomes
Overall Survival after BMT compare with chemotherapy.
Time frame: 1 year
Disease Free Survival after BMT compare with chemotherapy
Time frame: 1 year
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 22 Nov 2010.
Related trials for Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
Ardeshir Ghavamzadeh, MD study chair
Hematology-Oncology and SCT Research Center
1 site 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 Bone Marrow Transplantation and Chemotherapy in people with Acute Lymphoblastic Leukemia, run by Tehran University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 3 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 22 Nov 2010. 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 Iran. 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.
What does the primary outcome measure?
Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient (time frame: 1 year). 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 22 Nov 2010.