A Phase 2 interventional study of 5-Azacytidine in Chronic Lymphocytic Leukemia and Leukemia, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-30.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
The objective of this study is to determine the safety and efficacy of Azacytidine in fludarabine-resistant chronic lymphocytic leukemia (CLL), Richter's transformation, and T-cell prolymphocytic leukemia (T-PLL).
Azacytidine is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work better.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have blood drawn (about 3 teaspoons) to check your kidney and liver function (routine blood tests). You may have a bone marrow aspiration performed (if you have not had one in recent weeks). To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative urine pregnancy test.
If you agree to take part in this study, you will receive azacytidine by subcutaneous (just under the skin) injection every day for 7 days. This course of treatment will be repeated every 3-8 weeks, depending on the results of your routine blood tests.
Your doctor may increase or decrease your dose of azacytidine, depending on if you experience any side effects. You will continue to receive treatment on this study unless the disease gets worse or you experience any intolerable side effects. If the disease gets worse or you experience any intolerable side effects, you will be taken off this study.
This is an investigational study. This is an investigational study. Azacytidine has been approved by the FDA for the treatment of myelodysplastic syndrome. Up to 37 patients will take part in this study. All will be enrolled at M. D. Anderson.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 9 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
5-Azacytidine 75mg/m\^2 subcutaneously daily for seven days. Treatment cycles will be repeated every 3-8 weeks.
Drug: 5-Azacytidine
Starting dose level: 75mg/m\^2 subcutaneously daily for seven days. Treatment cycles will be repeated every 3-8 weeks.
Also known as: Azacytidine, Vidaza, 5-aza, 5-AZC, AZA-CR, Ladakamycin, NSC-102816
Tumor Response Rate (Complete, Partial) of Azacytidine
Overall response rate includes percentage of participants with complete response (CR) plus partial response (PR) responses using the National Cancer Institute (NCI) International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for response: Complete response defined as no palpable lymph nodes, liver or spleen and absence of symptoms. Neutrophil count \> 15,00/Mic L, and platelet count more than 100,000/MicL. Hemoglobin should be \> 11g/dl without transfusions. Lymphocyte count \<4000/micL. On bone marrow aspirate lymphocyte % should be \<30%, and biopsy showing no lymphocyte infiltrate. A partial response was defined as more than or equal to 50% decrease in lymph nodes and liver and spleen size. Neutrophils \> 1500/ micL or \>50 % improvement from baseline, platelet count \>100,000/micL or \>50 % improvement from baseline. Hemoglobin \>11g/dl or \>50% improvement from baseline. A reduction of \>50% in Leukocyte count or \<30 % lymphocytes with residual disease on biopsy for nodular PR.
Time frame: 3 to 8 weeks treatment cycles, continuation up to 1 year
Recruitment Period: 09/21/2006 to 12/01/2010. All recruitment done at The University of Texas MD Anderson Cancer Center.
| Milestone | 5-Azacytidine |
|---|---|
| Started | 9 |
| Completed | 9 |
| Not completed | 0 |
Overall response rate includes percentage of participants with complete response (CR) plus partial response (PR) responses using the National Cancer Institute (NCI) International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for response: Complete response defined as no palpable lymph nodes, liver or spleen and absence of symptoms. Neutrophil count \> 15,00/Mic L, and platelet count more than 100,000/MicL. Hemoglobin should be \> 11g/dl without transfusions. Lymphocyte count \<4000/micL. On bone marrow aspirate lymphocyte % should be \<30%, and biopsy showing no lymphocyte infiltrate. A partial response was defined as more than or equal to 50% decrease in lymph nodes and liver and spleen size. Neutrophils \> 1500/ micL or \>50 % improvement from baseline, platelet count \>100,000/micL or \>50 % improvement from baseline. Hemoglobin \>11g/dl or \>50% improvement from baseline. A reduction of \>50% in Leukocyte count or \<30 % lymphocytes with residual disease on biopsy for nodular PR.
| percentage of participants | 5-Azacytidine |
|---|---|
| Tumor Response Rate (Complete, Partial) of Azacytidine | 0 |
Collected over Adverse event data collected with each 7 day treatment through subsequent repeated treatment cycles every 3 to 8 weeks with continuation up to 1 year. Overall collection period: October 2006 to August 2009.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 5-Azacytidine | — | 0/9 (0%) | 9/9 (100%) |
| Event | 5-Azacytidine |
|---|---|
| InfectionsInfections and infestations | 6/9 |
| NeutropeniaBlood and lymphatic system disorders | 3/9 |
| Skin RashSkin and subcutaneous tissue disorders | 3/9 |
| PneumoniaInfections and infestations | 3/9 |
| NauseaGastrointestinal disorders | 3/9 |
| Shortness of breathRespiratory, thoracic and mediastinal disorders | 3/9 |
| DiarrheaGastrointestinal disorders | 2/9 |
| FeverGeneral disorders | 2/9 |
| VomitingGastrointestinal disorders | 2/9 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/9 |
| Age, Continuous(years) | 5-Azacytidine |
|---|---|
| Median | 74 (49 to 81) |
| Sex: Female, Male(Participants) | 5-Azacytidine |
|---|---|
| Female | 3 |
| Male | 6 |
| Region of Enrollment(participants) | 5-Azacytidine |
|---|---|
| United States | 9 |
This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center