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

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IDA-Etoposide Intensified Conditioning

Group Type EXPERIMENTAL

IDA

Intervention Type DRUG

Idarubicin: 15mg/m2/d: -8-\>-6d

TBI

Intervention Type RADIATION

TBI: 4.5 Gy/d, -5d, -4d

CTX

Intervention Type DRUG

CY:60mg/kg/d, -3d, -2d

VP-16

Intervention Type DRUG

VP-16: 15mg/kg, -2d, -1d

Non-IDA Conditioning

Group Type ACTIVE_COMPARATOR

TBI

Intervention Type RADIATION

TBI: 4.5 Gy/d, -5d, -4d

CTX

Intervention Type DRUG

CY:60mg/kg/d, -3d, -2d

VP-16

Intervention Type DRUG

VP-16: 15mg/kg, -2d, -1d

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qifa Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Hematologym, Nanfang Hospital, Southern Medical University, China

Reach out to these primary contacts for questions about participation or study logistics.

Hongsheng Zhou, PhD MD

Role: CONTACT

[email protected]

86-20-62787883

Qifa Liu, MD

Role: CONTACT

[email protected]

86-20-61641612

Facility Contacts

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Jianda Hu, MD

Role: primary

Yang Xiao, MD

Role: primary

[email protected]

Suijin Wu, MD

Role: primary

[email protected]

Role: primary

[email protected]

Shunqing Wang, MD

Role: primary

Huo Tan, MD PhD

Role: primary

Yuhua Li, MD PhD

Role: primary

[email protected]

Xiaojun Xu, MD

Role: primary

[email protected]

Yongrong Lai, MD

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Study Results

Basic Information

Brief Summary

Related Clinical Trials

Intensified Conditioning Regimen With High-Dose-Etoposide for Allo-HSCT for Adult Acute Lymphoblastic Leukemia

Comparing the Consolidation Regimens of IDA With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone for Elderly AML Patients

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Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy

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Detailed Description

Conditions

Study Design

Study Groups

IDA-Etoposide Intensified Conditioning

IDA

TBI

CTX

VP-16

Non-IDA Conditioning

TBI

CTX

VP-16

Interventions

IDA

TBI

CTX

VP-16

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Nanfang Hospital, Southern Medical University

Responsible Party

Principal Investigators

Qifa Liu, MD

Locations

Department of Hematology, Union Hospital of Fujian Medical University

Guangzhou General Hospital of Guangzhou Military Command

Guangdong General Hospital

Guangdong No.2 Provincial People's Hospital

Department of Hematology, Nanfang Hospital, Southern Medical University

Third Affiliated Hospital, Sun Yat-Sen University

Department of Hematology, 1st Guangzhou People Hospital

Oncology-Hematology Center, 1st Affiliated Hospital, Guangzhou Medical Collgege

Zhujiang Hospital of Southern Medical University

Zhongshan People Hospital,Guangdong

Department of Hematology, 1st Affiliated Hospital of Guangxi Medical University

Department of Hematology, Union Hospital, Huazhong Science and Technology

Department of Hematology, Tongji Hospital, Huazhong Science and Technology

Countries

Central Contacts

Hongsheng Zhou, PhD MD

Qifa Liu, MD

Facility Contacts

Jianda Hu, MD

Yang Xiao, MD

Suijin Wu, MD

Qing Zhang, MD

Hongsheng Zhou, MD PhD

Qifa Liu, MD

Dongjun Lin, MD

Shunqing Wang, MD

Huo Tan, MD PhD

Yuhua Li, MD PhD

Xiaojun Xu, MD

Yongrong Lai, MD

Yu Hu, MD PhD

Jianfeng Zhou, MD PhD

Related Links

Other Identifiers

HIE-ALL-2013

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