Clinical trial · Interventional
Safety Study of Parathyroid Hormone in Patients Needing Additional Stem Cell Mobilization.
Phase I Study of Parathyroid Hormone in Combination With G-CSF in Patients Requiring Additional Stem Cell Mobilization
NCT00299780CI-TRIAL-00000700completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine the safety of parathyroid hormone in combination with G-CSF when used as a stem cell mobilization regimen for patients who fail to mobilize sufficient progenitor stem cells after one or two attempts.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stem cell mobilization | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess safety of parathyroid hormone in combination with G-CSF when used as a mobilization agent at four different dosing levels.
Secondary outcomes (6)
- measure
- To evaluate the peripheral blood CD34+ count after second mobilization.
- measure
- To evaluate CD34+ cells/kg from apheresis after second mobilization.
- measure
- To evaluate the percent of patients for whom adequate numbers of CD34+ cells are obtained.
- measure
- To evaluate transfusion support.
- measure
- To evaluate the days to neutrophil engraftment (ANC >500) post autologous transplant.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Disease status: NHL or HD refractory to chemotherapy, relapsed, o high risk first remission; multiple myeloma; AML in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder. * Failed one or two mobilization attempts. * ECOG performance status of 0, 1, or 2. Exclusion Criteria: * Cardiac disease: symptomatic congestive heart failure, angina pectoris or uncontrolled hypertension * Pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease. * Renal disease: serum creatinine \> 2 mg/dl * Hepatic disease: SGOT or SGPT \> 3x normal; serum bilirubin \> 2.0 mg/dl that is not due to Gilbert's syndrome or hemolysis * Calcium \> 10.5 * Phosphate \< 1.6 * Uncontrolled infection * Pregnancy or breast feeding mother
References
Publications (0)
Data not yet available
No reference posted for this study.