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| Name | Class |
|---|---|
| The First People's Hospital of Changzhou | OTHER |
| Zhongda Hospital | OTHER |
| Suzhou Municipal Hospital | OTHER |
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To explore the efficiency and safety of CLAG regimen in R/R ALL
R/R Acute Lymphoblastic Leukemia has poor response to second-line chemotherapy.Here,we want to explore efficiency and safety of CLAG regimen in R/R ALL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLAG arm | Experimental | Cladribine (5 mg/m2)should be intravenous use on day 1-5, granulocyte colony-stimulating factor will be hypodermic injection using 300 μg per day on days 0-5,cytarabine (1.5 mg/m2) every 12 hours, intravenous infusion on day1-5,4 weeks per cycle. |
|
| Control arm | Active Comparator | Patients in the control arm received the investigator's choice of one of the following three regimens:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cladribine | Drug | Cladribine combine with cytarabine will be intravenous on days 1-5; G-CSF will be hypodermic injection on day0-5,4 weeks per cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| CR (complete remission rate) | Response to CLAG regimen. | the first cycle (4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival(OS) | The time from randomization to death from any cause. | From the 1st day to the 365th day after enrollment. |
| Progression-Free Survival (PFS) | It is defined as the total survival of a patient after CR until the tumor recurrence or death from any cause. |
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Inclusion Criteria:
The patients meet the diagnostic criteria for Relapsed/Refractroy B-ALL. ECOG score is 0-3. Expecting life span is more than 6 weeks.
Exclusion Criteria:
Patients are combined with severe organ dysfunction or organ failure: Cardiac failure, Liver and kidney insufficiency.
Patients are combined with severe infection or other complications that can not tolerate chemotherapy.
Patients are considered as other tumor progression. Patients have used cladribine. Pregnant and lactating women will not be included.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huizhu Kang, MD | Contact | 8761925608 | khz11826@sina.com | |
| Meng Zhou, MD | Contact | 15606133002 | zhoumeng@suda.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yue Han, MD/PhD | Study Principle investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22493293 | Background | Gokbuget N, Stanze D, Beck J, Diedrich H, Horst HA, Huttmann A, Kobbe G, Kreuzer KA, Leimer L, Reichle A, Schaich M, Schwartz S, Serve H, Starck M, Stelljes M, Stuhlmann R, Viardot A, Wendelin K, Freund M, Hoelzer D; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Outcome of relapsed adult lymphoblastic leukemia depends on response to salvage chemotherapy, prognostic factors, and performance of stem cell transplantation. Blood. 2012 Sep 6;120(10):2032-41. doi: 10.1182/blood-2011-12-399287. Epub 2012 Apr 4. |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017338 | Cladribine |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003561 | Cytarabine |
| C024352 | fludarabine |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D015762 | 2-Chloroadenosine |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
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| Fludarabine | Drug | Control arm Patients in the control arm received the investigator's choice of one of the following three regimens: FLAG:Fludarabine(30mg/m2)should be intravenous use on day 1-5, granulocyte colony-stimulating factor will be hypodermic injection using 300 μg per day on days 0-5,cytarabine (1.5 mg/m2) every 12 hours, intravenous infusion on day1-5,4 weeks per cycle. a high-dose cytosine arabinoside-based regimen; a high-dose methotrexate-based regimen |
|
|
| From the 1st day to the 365th day after enrollment. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003839 | Deoxyadenosines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |