HD-Idarubicin/Etoposide Intensified Conditioning Regimen Allo-HSCT for Adult ALL (HITA)

October 7, 2015 updated by: Nanfang Hospital of Southern Medical University

An Open-label,Multi-center,Prospective Study of Idarubicin and Etoposide Intensified Conditioning Regimen Allogeneic Hematopoietic Stem Cell Transplantation for Adult Acute Lymphoblastic Leukemia

Intensified conditioning regimen allo-HSCT is based on a hypothesis of that intensifying condition with less-used drugs could overcome resistance,reduce tumor burden, and most importantly, spare enough time for slow-growing GVL effect following immune reconstitution to finally get rid of MRD and control the disease. Our previous trial of HDE-ALL-2011 (NCT01457040) have confirmed the role of intensified conditioning allo-HSCT in adult ALL, resulting in significantly improved OS and EFS in comparison with previous standard TBI/CY2 conditioning regimen(data not yet published). But at the same time, FA-TBI/CY2-VP16 conditioning regimen was associated with high transplantation-related mortality (TRM), which might be attributed to excessive suppression on both bone marrow and immune. TT-ALL-HIE-2013, substituting FA with idarubicin, is aimed at maintaining anti-tumor effect with less cross-resistance and immune suppression and reducing TRM.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It's well-known that the long-term outcome of adult acute lymphoblastic leukemia (ALL) lags far behind that of pediatric ALL,associated with different molecular cytogenetics make-up and treatment strategies. In search of an optimal regimen for pediatric ALL, comprehensive series of clinical trials of intensive chemotherapies have been conducted and lead to 80%-90% long-term survival. At the same time, pediatric-inspired chemotherapy protocol aslo yielded a charming result of 50-60% 3-year EFS in adolescent and young adult. In comparison with the leading role of intensive chemotherapy in pediatric ALL, allogeneic hematopoietic stem cell transplantation (allo-HSCT) plays an important role in treatment strategy of adult ALL. According to the state-of-art understanding of ALL, total therapy of ALL should consist of molecular-cytogenetics classification at diagnosis, minimal residual disease (MRD) monitoring and redefining risk classification during treatment, pediatric-inspired chemotherapy with high-dose Methotrexate/L-asparaginase during consolidation therapy,furthermore,risk/MRD-adapted allo-HSCT for high-risk and refractory/relapsed ALL.In pre-pediatric-inspired protocol era, allo-HSCT still represents the major role for improving the outcome of adult ALL, especially for high-risk and refractory/relapsed ALL. It's established that graft-versus-leukemia (GVL) effect was weak in ALL and patient shows poor response for donor-lymphocyte infusion (DLI). Intensified conditioning regimen allo-HSCT is based on a hypothesis of that intensifying condition with less-used drugs could overcome resistance,reduce tumor burden, and most importantly, spare enough time for slow-growing GVL effect following immune reconstitution to finally get rid of MRD and control the disease. Our previous trial of HDE-ALL-2011 (NCT01457040) have confirmed the role of intensified conditioning allo-HSCT in adult ALL, resulting in significantly improved OS and EFS in comparison with previous standard TBI/CY2 conditioning regimen(data not yet published). But at the same time, FA-TBI/CY2-VP16 conditioning regimen was associated with high transplantation-related mortality (TRM), which might be attributed to excessive suppression on both bone marrow and immune. TT-ALL-HIE-2013, substituting FA with idarubicin, is aimed at maintaining anti-tumor effect with less cross-resistance and immune suppression and reducing TRM.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Department of Hematology, Union Hospital of Fujian Medical University
        • Contact:
          • Jianda Hu, MD
        • Principal Investigator:
          • Jianda Hu, MD
    • Guangdong
      • Guangzhou, Guangdong, China, 510010
        • Recruiting
        • Guangzhou General Hospital of Guangzhou Military Command
        • Contact:
        • Principal Investigator:
          • Yang Xiao, MD
      • Guangzhou, Guangdong, China, 510030
        • Recruiting
        • Guangdong General Hospital
        • Contact:
        • Principal Investigator:
          • Suijin Wu, MD
      • Guangzhou, Guangdong, China, 510317
        • Recruiting
        • Guangdong No.2 Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Qing Zhang, MD
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Third Affiliated Hospital, Sun Yat-Sen University
        • Contact:
        • Principal Investigator:
          • Dongjun Lin, MD
      • Guangzhou, Guangdong, China
        • Recruiting
        • Zhujiang Hospital of Southern Medical University
        • Contact:
        • Principal Investigator:
          • Yuhua Li, MD PhD
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Department of Hematology, Nanfang Hospital, Southern Medical University
        • Contact:
        • Sub-Investigator:
          • Hongsheng Zhou, MD PhD
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Department of Hematology, 1st Guangzhou People Hospital
        • Contact:
          • Shunqing Wang, MD
        • Principal Investigator:
          • Shunqing Wang, MD
      • Guangzhou, Guangdong, China
        • Recruiting
        • Oncology-Hematology Center, 1st Affiliated Hospital, Guangzhou Medical Collgege
        • Contact:
          • Huo Tan, MD PhD
        • Principal Investigator:
          • Huo Tan, MD PhD
      • Zhongshan, Guangdong, China, 528403
        • Recruiting
        • Zhongshan People Hospital,Guangdong
        • Contact:
        • Principal Investigator:
          • Xiaojun Xu, MD
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Department of Hematology, 1st Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Yongrong Lai, MD
        • Principal Investigator:
          • Yongrong Lai, MD
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Department of Hematology, Union Hospital, Huazhong Science and Technology
        • Contact:
          • Yu Hu, MD PhD
        • Principal Investigator:
          • Yu Hu, MD PhD
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Department of Hematology, Tongji Hospital, Huazhong Science and Technology
        • Contact:
        • Principal Investigator:
          • Jianfeng Zhou, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: 16 years to 65 years;
  2. Diagnosis of acute lymphoblastic leukemia;
  3. Patient receives allo-HSCT;
  4. The informed consent form has been signed;

Exclusion Criteria:

  1. Patient with severe cardiac dysfunction with less than 50% EF;
  2. Patient with severe lung dysfunction;
  3. Patient with more than 3 times ULN of serum ALT or AST levels, or with more than 2 times ULN of serum TBIL level, or less than 40% of normal prothrombin time activity (PTA); or with more than 2 times the ULN of serum Cr;
  4. Patient with severe active infection;
  5. Patient with allergy history about suspected drug in conditioning regimen;
  6. Patient with other conditions considered unsuitable for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IDA-Etoposide Intensified Conditioning
Drug: IDA
Idarubicin: 15mg/m2/d: -8->-6d
Other Names:
  • Idarubicin
Radiation: TBI
TBI: 4.5 Gy/d, -5d, -4d
Other Names:
  • Total Body Irradiation
Drug: CTX
CY:60mg/kg/d, -3d, -2d
Other Names:
  • Cyclophosphamide
Drug: VP-16
VP-16: 15mg/kg, -2d, -1d
Other Names:
  • Etoposide
Active Comparator: Non-IDA Conditioning
Radiation: TBI
TBI: 4.5 Gy/d, -5d, -4d
Other Names:
  • Total Body Irradiation
Drug: CTX
CY:60mg/kg/d, -3d, -2d
Other Names:
  • Cyclophosphamide
Drug: VP-16
VP-16: 15mg/kg, -2d, -1d
Other Names:
  • Etoposide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event-Free Survival
Time Frame: 3 year
3 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Transplantation-Related Mortality
Time Frame: 3 year
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: Qifa Liu, MD, Department of Hematologym, Nanfang Hospital, Southern Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

June 6, 2013

First Submitted That Met QC Criteria

June 7, 2013

First Posted (Estimate)

June 10, 2013

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIE-ALL-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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