Clinical trial · Interventional
ATRA Plus G-CSF for Mobilization of Hematopoietic Stem and Progenitor Cells
A Phase I Study of Haematopoietic Stem Cell Mobilization Using G-CSF With ATRA in Patients With Cutaneous Lymphoma and Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hematopoietic stem and progenitor cells (HSPC) are used for transplantation in patients undergoing high dose therapy for the treatment of a range of cancers. * HSPC are collected from the bloodstream after treatment with medications that cause the HSPC to move from the bone marrow into the bloodstream, a process called mobilization * between 5 and 60% of patients can fail to collect enough HSPC for a transplant, using current mobilization techniques * this study aims to assess the safety of combining a derivative of vitamin A, ATRA with G-CSF (the drug most commonly used to mobilize HSPC) * ATRA has never been combined with G-CSF for mobilization of HSPC and therefore a study is needed to assess the safety of this combination, and whether it successfully mobilizes HSPC
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Lymphoma | Cutaneous Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATRA plus G-CSF (filgrastim, NEUPOGEN (R)) combination | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (14)
- measure
- Toxicity data (NCI-CTC version 2.0 criteria)
- measure
- skin toxicity
- measure
- hepatotoxicity
- measure
- mucosal toxicity
- measure
- hematologic toxicity
- measure
- neurologic toxicity
- measure
- treatment response
- measure
- CD34+ cell count peak level
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * likely to comply with study protocol * age of 18-70 * histologically proven multiple myeloma or lymphoma * not currently receiving cytotoxic agents however thalidomide, prednisolone, dexamethasone are allowable * multiple myeloma patients must be receiving regular bisphosphonates * absolute neutrophil count between 1.5 and 10.0 x 10\^9/L * ECOG performance status \</= 3 * life expectancy of at least two months * written informed consent signed by patient or legally authorised representative Exclusion Criteria: * use of other vitamin A preparations within the last 30 days * active infection or fever \>/= 38.2 degrees celsius * pregnancy or breast feeding. Women of child bearing potential admitted to the trial must take adequate measures to prevent conception (at least two different forms of contraception) and are to undergo a pregnancy test. Oral contraception must not include low-dose progestogens * known allergy to E.coli derived products * current treatment with tetracycline antibiotics
References
Publications (1)
- BACKGROUNDHerbert KE, Walkley CR, Winkler IG, Hendy J, Olsen GH, Yuan YD, Chandraratna RA, Prince HM, Levesque JP, Purton LE. Granulocyte colony-stimulating factor and an RARalpha specific agonist, VTP195183, synergize to enhance the mobilization of hematopoietic progenitor cells. Transplantation. 2007 Feb 27;83(4):375-84. doi: 10.1097/01.tp.0000251376.75347.b4. PMID 17318068