CTRI/2014/06/004676
Recruiting
Phase 2
Phase II trial to study if the addition of fludarabine to the standard regimen of Anti-thymocyte globulin (ATG) and cyclosporine will improve remission rates in patients with severe and very severe aplastic anemia (SAA/VSAA)
INVESTIGATOR INITIATED STUDY0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- PATIENTS WITH APLASIC ANEMIA
- Sponsor
- INVESTIGATOR INITIATED STUDY
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients with SAA or VSAA who give consent for the trial \[Definition of SAA is as per Camitta et al â?? Bone marrow cellularity \< 25% with 2 out of the following 3 criteria â?? Neutrophils \< 0\.5 x 109/L, Platelet count \< 20 x 109/L, reticulocyte count \< 20 x 109/L]; VSAA defined as Neutrophils \< 0\.2 x 109/L with all other criteria of SAA
Exclusion Criteria
- •1\. Children 15 years of age
- •2\. Patients with any abnormalities suggestive of congenital bone marrow failure syndromes such as Fanconiâ??s anemia or Dyskeratosis congenita
- •3\. Patients who had active infection requiring admission within 2 weeks prior to ATG
- •4\. Pregnancy
- •5\. Creatinine 1\.4 mg/dl
- •6\. Prior history of treatment with ATG
- •7\. Seropositivity for HIV, Hepatitis B or C
- •8\. Any other significant co\-morbidities that make death likely in the next 4 weeks.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Terminated
Phase 2
Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell LymphomaMantle Cell LymphomaNCT00183989University of Southern California30
Completed
Phase 2
FCM-R (Fludarabine, Cyclophosphamide, Mitoxantrone, Rituximab) in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) < 70 YearsChronic Lymphocytic LeukemiaNCT00254410M.D. Anderson Cancer Center30
Active, not recruiting
Not Applicable
Multicentric Pilot Phase II Study for use of Fludarabine plus Cyclophosphamide Followed by 90 Y-Ibritumomab Tiuxetan Zevalin in the Treatment of non-Follicular Indolent Lymphomas Refractory or Relapsed after Conventional Front-Line Chemotherapy not Containing FludarabineTreatment patients with non-Follicular Indolent Lymphomas Refractory or Relapsed after Conventional Front-Line Chemotherapy not Containing Fludarabine and CiclofosfamideEUCTR2005-000699-41-ITAZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO A.O. DI RILIEVO NAZIONALE80
Terminated
Phase 2
Fludarabine in Combination With Daunorubicin and Cytarabine Liposome in Newly-diagnosed Acute Myeloid Leukemia.Acute Myeloid Leukemia, AdultAMLAML, AdultNCT04425655University of California, San Diego2
Active, not recruiting
Not Applicable
Phase II trial to evaluate the combination of FOLFOX6 + Bevacizumab in initially unresectable liver metastases from colorectal cancerMETASTHATIC COLON-RECTUM AND KIDNEY CANCERMedDRA version: 9.1Level: LLTClassification code 10055114Term: Colon cancer metastaticEUCTR2005-002269-35-ITAZIENDA OSPEDALIERA POLICLINICO DI MODENA