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Completed

NCT Number: NCT01015261

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

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hematology-Oncology & SCT Research Center

Tehran, Tehran Province, 14114, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone Marrow Transplantation

Procedure

Allogenic Bone Marrow Transplantation

Chemotherapy

Procedure
  • Cyclophosphamide 1200 mg/m2 D15
  • Daunorubicin 45 mg/m2 D15-D18
  • Vincristine 1 mg/m2 D15, D22
  • Dexamethasone 24 mg/d D12-D28

Primary outcomes

  1. Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient

    Time frame: 1 year

Secondary outcomes

  1. Overall Survival after BMT compare with chemotherapy.

    Time frame: 1 year

  2. Disease Free Survival after BMT compare with chemotherapy

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

Comparison of Efficacy of Allogenic Bone Marrow Transplantation With Cytoreduction and Chemotherapy in ALL Patients

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 18, 2009
Registry last updated
Nov 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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