Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon
Study connect Webseite durchsuchen

Active, Not Recruiting

A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes - CC-90009-AML-001

Aktualisiert: 27 September, 2023   |   ClinicalTrials.gov

Celgene ist eine reine Tochtergesellschaft von Bristol-Myers Squibb

SIND SIE AN DIESER STUDIE INTERESSIERT?
Drucken Sie diese Seite und den Leitfaden zu klinischen Studien aus, damit Sie sie mit Ihrem Arzt besprechen können.
Nutzen Sie unseren Leitfaden zu klinischen Studien, um mehr über die Schritte für die Teilnahme zu erfahren. Informieren Sie sich über die wichtigsten Punkte, über die Sie nachdenken sollten, und die Fragen, die Sie dem Studienteam stellen sollten, bevor Sie sich für eine Teilnahme entscheiden.

Studiendetails

  • Phase 1

    Phase

  • Geschlecht(er)

  • 18+

    Altersgruppe

  • Active, Not Recruiting

Behandlungsmöglichkeiten

Studienarme
ZUGEWIESENE BEHANDLUNG
Experimental: CC-90009 - Part A
Drug: CC-90009
Experimental: CC-90009 - Part B - AML and MDS patients
Drug: CC-90009

Wichtigste Eignungskriterien

Inclusion Criteria: 1. Men and women ≥ 18 years of age, at the time of signing the ICD (Informed Consent Document). 2. Subject must understand and voluntarily sign an ICD prior to any study-related assessments/procedures being conducted. 3. Relapsed or refractory AML (Acute Myeloid Leukemia) (Parts A and B) or relapsed or refractory high-risk MDS (Myelodysplastic Syndrome) (Part B only) as defined by World Health Organization criteria who are not suitable for other established therapies. 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2. 5. At least 4 weeks (from first dose) has elapsed from donor lymphocyte infusion (DLI) without conditioning. 6. Subjects must have the following screening laboratory values: - Total White Blood Cell count (WBC) < 25 x 109/L prior to first infusion. Prior or concurrent treatment with hydroxyurea to achieve this level is allowed. - Selected electrolytes within normal limits or correctable with supplements. - Serum bilirubin ≤ 1.5 x ULN (upper limit of normal). - Estimated serum creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gault equation. 7. Agree to follow the CC-90009 Pregnancy Prevention Plan (PPP) Exclusion Criteria: 1. Subjects with acute promyelocytic leukemia (APL) 2. Subjects with clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid is only required if there is clinical suspicion of CNS involvement by leukemia during screening. 3. Patients with prior autologous hematopoietic stem cell transplant who, in the investigator's judgment, have not fully recovered from the effects of the last transplant (e.g., transplant related side effects). 4. Prior allogeneic hematopoietic stem cell transplant (HSCT) with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90009. 5. Subjects on systemic immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). The use of topical steroids for ongoing skin or ocular GVHD is permitted. 6. Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting CC-90009, whichever is shorter. Hydroxyurea is allowed to control peripheral leukemia blasts. 7. Leukapheresis ≤ 2 weeks prior to starting CC-90009.

Wir empfehlen Ihnen dringend, sich an Bristol Myers Squibb zu wenden, um Nebenwirkungen (unerwünschte Ereignisse) zu melden.
Nebenwirkungen (unerwünschte Ereignisse) und andere meldepflichtige Ereignisse werden hier definiert
Nebenwirkungen (unerwünschte Ereignisse) oder Produktqualitätsbeschwerden melden: Medizinische Information