EUCTR2006-006978-20-GB
Active, not recruiting
Not Applicable
A Phase 2 Study to Evaluate the Safety and Efficacy of Weekly Doses of Marqibo® (vincristine sulfate liposomes injection) in Adult Patients with Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia (ALL) in Second Relapse or Adult Patients with Philadelphia Chromosome-negative ALL Who Failed Two Treatment Lines of Anti-leukemia Chemotherapy
Hana Biosciences, Inc.0 sites56 target enrollmentDecember 14, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia
- Sponsor
- Hana Biosciences, Inc.
- Enrollment
- 56
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \=18 years.
- •2 Have Philadelphia chromosome\-negative ALL or lymphoblastic lymphoma
- •and be in second relapse or have failed two treatment lines of anti\-leukemia
- •chemotherapy.
- •3 Have histologically or cytologically proven ALL and \=10% bone marrow
- •blasts. If \< 10% bone marrow blasts, subject must have histologically or
- •cytologically proven ALL and evaluable extramedullary disease.
- •4 Have achieved a complete response to at least one prior anti\-leukemia therapy
- •as defined by a leukemia\-free interval of \= 90 days.
- •5 For subjects with a prior history of stem cell transplantation, have a 6 Have ECOG performance status 0–3\.
Exclusion Criteria
- •1\. Have Burkitt’s lymphoma or Burkitt’s leukemia
- •2\. Have a history of Philadelphia chromosome\-positive ALL and/or BCR/ABL
- •rearrangements documented by FISH or PCR.
- •3\. Have active CNS disease. History of treated CNS disease is allowable. The CNS disease
- •must have resolved in order for the subject to be eligible.
- •4\. Are eligible for stem cell transplantation. This implies that a suitable donor is readily available, the subject is willing to undergo stem cell transplantation, and the Investigator believes this is a better treatment option than Marqibo. This is at the Investigator’s discretion.
- •5\. Are treated with any investigational agents or chemotherapy agents in the last 21 days before the first dose of Marqibo, unless full recovery from side effects has occurred or the subject has rapidly progressing disease judged to be life threatening by the Investigator.
- •6\. Are receiving any other standard or investigational treatment for their leukemia.
- •a. Intrathecal chemotherapy for CNS prophylaxis is allowable.
- •b. The use of hydroxyurea (Hydrea®) to control leukocytosis is allowable but must be
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
A Phase 2 Study to Evaluate the Safety and Efficacy of Weekly Doses of Marqibo® (vincristine sulfate liposomes injection) in Adult Patients with Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia (ALL) in Second Relapse or Adult Patients with Philadelphia Chromosome-negative ALL Who Failed Two Treatment Lines of Anti-leukemia ChemotherapyEUCTR2006-006978-20-DETalon Therapeutics , Inc.65
Active, not recruiting
Phase 1
A study to evaluate the safety and efficacy of Lerociclib in participants with advanced breast cancerMetastatic Breast CancerMedDRA version: 20.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10006289Term: Benign and malignant breast neoplasmsSystem Organ Class: 100000004872MedDRA version: 20.0Level: HLTClassification code 10006290Term: Breast and nipple neoplasms malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2021-005238-40-BEEQRx, Inc.100
Completed
Not Applicable
A Phase 2 Study to Evaluate the Safety and Efficacy of nab®-Paclitaxel plus Gemcitabine in Korean Patients with Metastatic and Advanced Pancreatic Ductal AdenocarcinomaNeoplasmsKCT0003564Samsung Medical Center111
Active, not recruiting
Phase 1
A study to look at how safe and effective glofitamab plus R-CHOP in ctDNA high-risk people with untreated diffuse large B-cell lymphomaCTIS2023-504994-19-00F. Hoffmann-La Roche AG40
Active, not recruiting
Phase 2
The Safety and Efficacy of THVD-102, a combination of Oxybutynin and Pilocarpine, in Subjects with Primary Focal Hyperhidrosis.ACTRN12615000873527TheraVida, Inc21