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Allogenic Bone Marrow Transplantation (BMT) Compare With Cytoreduction and Chemotherapy in Acute Lymphoblastic Leukemia (ALL) Patients

NCT ID: NCT01015261

Last Updated: 2010-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia

Keywords

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ALL BMT Chemotherapy Allogenic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bone Marrow Transplantation

Group Type EXPERIMENTAL

Bone Marrow Transplantation

Intervention Type PROCEDURE

Allogenic Bone Marrow Transplantation

Chemotherapy

Group Type ACTIVE_COMPARATOR

Chemotherapy

Intervention Type PROCEDURE

1. 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

Interventions

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Bone Marrow Transplantation

Allogenic Bone Marrow Transplantation

Intervention Type PROCEDURE

Chemotherapy

1. 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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnose of Acute lymphoblastic leukemia
* Age between 16 to 50 year
* New case of ALL

Exclusion Criteria

* Primary CNS involvement
* Primary Testis involvement
* Previously treated
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Tehran University of Medical Sciences

Principal Investigators

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Ardeshir Ghavamzadeh, MD

Role: STUDY_CHAIR

Hematology-Oncology and SCT Research Center

Locations

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Hematology-Oncology & SCT Research Center

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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HORCSCT-0903

Identifier Type: -

Identifier Source: org_study_id