Acute Lymphoblastic LeukemiaPhase 4HITANCT01873807
HD-Idarubicin/Etoposide Intensified Conditioning Regimen Allo-HSCT for Adult ALL
A Phase 4 study testing IDA, TBI and CTX in people with Acute Lymphoblastic Leukemia, run by Nanfang Hospital, Southern Medical University at 13 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- IDA, TBI and CTX
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 13 sitesChina
- Study dates
- May 2013to Dec 2015
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: 16 years to 65 years;
- Diagnosis of acute lymphoblastic leukemia;
- Patient receives allo-HSCT;
- The informed consent form has been signed;
Who cannot join
- Patient with severe cardiac dysfunction with less than 50% EF;
- Patient with severe lung dysfunction;
- 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;
- Patient with severe active infection;
- Patient with allergy history about suspected drug in conditioning regimen;
- Patient with other conditions considered unsuitable for the study.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Department of Hematology, Union Hospital of Fujian Medical University
Fuzhou, Fujian
Jianda Hu, MD
Jianda Hu, MD
- Recruiting
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, 510010
Yang Xiao, MD, jdxiao111@163.com
Yang Xiao, MD
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510030
Suijin Wu, MD, songwu55555@163.com
Suijin Wu, MD
- Recruiting
Guangdong No.2 Provincial People's Hospital
Guangzhou, Guangdong, 510317
Qing Zhang, MD, zhqing@vip.163.com
Qing Zhang, MD
- Recruiting
Department of Hematology, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Hongsheng Zhou, MD PhD, 86-20-62787883, hanson2008@gmail.com
Qifa Liu, MD, 86-20-61641612, liuqifa628@163.com
- Recruiting
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510630
Dongjun Lin, MD, lindongjun0168@163.com
Dongjun Lin, MD
- Recruiting
Department of Hematology, 1st Guangzhou People Hospital
Guangzhou, Guangdong
Shunqing Wang, MD
Shunqing Wang, MD
- Recruiting
Oncology-Hematology Center, 1st Affiliated Hospital, Guangzhou Medical Collgege
Guangzhou, Guangdong
Huo Tan, MD PhD
Huo Tan, MD PhD
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
Yuhua Li, MD PhD, li_yuhua@yahoo.com
Yuhua Li, MD PhD
- Recruiting
Department of Hematology, 1st Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Yongrong Lai, MD
Yongrong Lai, MD
- Recruiting
Department of Hematology, Union Hospital, Huazhong Science and Technology
Wuhan, Hubei, 430022
Yu Hu, MD PhD
Yu Hu, MD PhD
- Recruiting
Department of Hematology, Tongji Hospital, Huazhong Science and Technology
Wuhan, Hubei, 430030
Jianfeng Zhou, MD PhD, jfzhou@tjh.tjmu.edu.cn
Jianfeng Zhou, MD PhD
- Recruiting
Zhongshan People Hospital,Guangdong
Zhongshan, Guangdong, 528403
Xiaojun Xu, MD, doctorxu@163.com
Xiaojun Xu, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- IDA, TBI, CTX, VP-16
- Keywords
- Idarubicin, Etoposide, HSCT, Acute Lymphoblastic Leukemia
- 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.
IDADrug
Also called Idarubicin
Idarubicin: 15mg/m2/d: -8->-6d
TBIRadiation
Also called Total Body Irradiation
TBI: 4.5 Gy/d, -5d, -4d
CTXDrug
Also called Cyclophosphamide
CY:60mg/kg/d, -3d, -2d
VP-16Drug
Also called Etoposide
VP-16: 15mg/kg, -2d, -1d
| Study group | Role | What they receive |
|---|---|---|
| IDA-Etoposide Intensified Conditioning | Experimental | Not described Receives: Drug: IDA; Radiation: TBI; Drug: CTX; Drug: VP-16 |
| Non-IDA Conditioning | Active comparator | Not described Receives: Radiation: TBI; Drug: CTX; Drug: VP-16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival
Measured: 3 year
Secondary outcomes (1)
Transplantation-Related Mortality
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
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.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qifa Liu, MD, Principal investigator, Department of Hematologym, Nanfang Hospital, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873807
- Sponsor's protocol ID
- HIE-ALL-2013
- Acronym
- HITA
- Status last verified
- Oct 2015
- First submitted
- 6 Jun 2013
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label,Multi-center,Prospective Study of Idarubicin and Etoposide Intensified Conditioning Regimen Allogeneic Hematopoietic Stem Cell Transplantation for Adult Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT01873807
- Acronym / sponsor ID
- HITA / HIE-ALL-2013
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Idarubicin, Etoposide, HSCT, Acute Lymphoblastic Leukemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 Jun 2013 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDA-Etoposide Intensified Conditioning | Experimental | Drug: IDA, Radiation: TBI, Drug: CTX, Drug: VP-16 |
| Non-IDA Conditioning | Active comparator | Radiation: TBI, Drug: CTX, Drug: VP-16 |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 16 years to 65 years;
- Diagnosis of acute lymphoblastic leukemia;
- Patient receives allo-HSCT;
- The informed consent form has been signed;
Key exclusion criteria (6 listed)
- Patient with severe cardiac dysfunction with less than 50% EF;
- Patient with severe lung dysfunction;
- 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;
- Patient with severe active infection;
- Patient with allergy history about suspected drug in conditioning regimen;
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 |
|---|---|---|
| IDAAlso: IdarubicinIdarubicin: 15mg/m2/d: -8->-6d | Drug | IDA-Etoposide Intensified Conditioning |
| TBIAlso: Total Body IrradiationTBI: 4.5 Gy/d, -5d, -4d | Radiation | IDA-Etoposide Intensified Conditioning, Non-IDA Conditioning |
| CTXAlso: CyclophosphamideCY:60mg/kg/d, -3d, -2d | Drug | IDA-Etoposide Intensified Conditioning, Non-IDA Conditioning |
| VP-16Also: EtoposideVP-16: 15mg/kg, -2d, -1d | Drug | IDA-Etoposide Intensified Conditioning, Non-IDA Conditioning |
Primary outcome
Event-Free Survival
Time frame: 3 year
1 secondary outcome
Transplantation-Related Mortality
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
- Website of Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.Link provided by the sponsor.
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.
Qifa Liu, MD principal investigator
Department of Hematologym, Nanfang Hospital, Southern Medical University, China
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IDA, TBI and CTX in people with Acute Lymphoblastic Leukemia, run by Nanfang Hospital, Southern Medical University at 13 sites in China.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongsheng Zhou, PhD MD (86-20-62787883, hanson2008@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Free Survival (time frame: 3 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 9 Oct 2015.