Diseases / Waldenstrom Macroglobulinemia
Waldenstrom Macroglobulinemia
DiseaseWaldenstrom macroglobulinemia is a rare indolent B-cell lymphoplasmacytic lymphoma with monoclonal IgM overproduction and marrow involvement. It can lead to hyperviscosity, neuropathy, cytopenias, and organ-related complications.
- Trials
- 520
- Recruiting
- 43
- Completed
- 307
- With results
- 156
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Unknown | Approved for marketing | No longer available | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | — | — | — | — | 4 | — | — | — | — | — | 4 |
| Phase 1 | 14 | 1 | — | 6 | 94 | 25 | 5 | 4 | — | — | 149 |
| Phase 1/2 | 4 | 1 | — | 4 | 35 | 12 | 2 | 4 | — | — | 62 |
| Phase 2 | 7 | 5 | — | 14 | 115 | 28 | 10 | 9 | — | — | 188 |
| Phase 2/3 | 1 | — | — | — | 1 | — | — | — | — | — | 2 |
| Phase 3 | 1 | 1 | — | — | 21 | 2 | — | 4 | — | — | 29 |
| Phase 4 | 1 | 1 | — | 1 | 5 | — | — | — | — | — | 8 |
| Not applicable | 4 | 2 | — | — | 16 | 6 | 4 | — | — | — | 32 |
| Unknown | 11 | 2 | 1 | 5 | 16 | 3 | 3 | 2 | 1 | 2 | 46 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Waldenstrom Macroglobulinemia | 4 | 149 | 62 | 188 | 2 | 29 | 8 | 32 | 46 | 520 |
| Leukemia, Lymphocytic, Chronic, B-Cell | 4 | 117 | 42 | 99 | 1 | 23 | 2 | 26 | 30 | 344 |
| Lymphoma, B-Cell, Marginal Zone | 3 | 125 | 42 | 101 | 1 | 20 | 1 | 24 | 26 | 343 |
| Lymphoma, Follicular | 3 | 120 | 44 | 96 | 1 | 21 | 1 | 24 | 22 | 332 |
| Lymphoma, Mantle-Cell | 3 | 121 | 41 | 78 | 1 | 21 | 1 | 23 | 24 | 313 |
| Lymphoma, Non-Hodgkin | 3 | 96 | 32 | 80 | 1 | 18 | 1 | 23 | 21 | 275 |
| Lymphoma, Large B-Cell, Diffuse | 3 | 96 | 34 | 71 | 1 | 20 | 1 | 21 | 20 | 267 |
| Burkitt Lymphoma | 2 | 84 | 25 | 59 | 1 | 15 | 1 | 21 | 18 | 226 |
| Precursor Cell Lymphoblastic Leukemia-Lymphoma | 2 | 77 | 20 | 61 | 1 | 16 | 1 | 22 | 20 | 220 |
| Lymphoma, Large-Cell, Immunoblastic | 2 | 68 | 18 | 56 | 1 | 17 | 1 | 20 | 17 | 200 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | National Cancer Institute (NCI) | 51 | 0 |
| 2 | Fred Hutchinson Cancer Center | 36 | 2 |
| 3 | Dana-Farber Cancer Institute | 26 | 0 |
| 4 | Mayo Clinic | 18 | 1 |
| 5 | Memorial Sloan Kettering Cancer Center | 13 | 3 |
| 6 | Roswell Park Cancer Institute | 11 | 1 |
| 7 | City of Hope Medical Center | 10 | 0 |
| 8 | Case Comprehensive Cancer Center | 9 | 1 |
| 9 | Jonsson Comprehensive Cancer Center | 9 | 1 |
| 10 | M.D. Anderson Cancer Center | 9 | 0 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Rituximab | 101 |
| 2 | Cyclophosphamide | 63 |
| 3 | fludarabine phosphate | 55 |
| 4 | Peripheral Blood Stem Cell Transplantation | 52 |
| 5 | Mycophenolic Acid | 34 |
| 6 | Bortezomib | 33 |
| 7 | Whole-Body Irradiation | 33 |
| 8 | ibrutinib | 29 |
| 9 | Dexamethasone | 28 |
| 10 | Tacrolimus | 26 |
Evidence
- Results reported
- 50.8%156 of 307 completed
- Published
- 20.2%62 of 307 completed
- Primary endpoint met
- 31.2%5 of 16 analyses
- Median months to report
- 24
Documents disclosed
Trial profile
- Median enrollment
- 39
- Median duration
- 62.2months
- Countries
- 44
- Study sites
- 3051
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 32
- Phase 1
- 30
- Phase 1/2
- 45
- Phase 2
- 37
- Phase 2/3
- 255
- Phase 3
- 219
- Phase 4
- 45
- Not applicable
- 39
- Unknown
- 141
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Boston | United States | 80 |
| 2 | New York | United States | 78 |
| 3 | Seattle | United States | 76 |
| 4 | Rochester | United States | 54 |
| 5 | Houston | United States | 50 |
| 6 | Columbus | United States | 42 |
| 7 | Denver | United States | 37 |
| 8 | Chicago | United States | 36 |
| 9 | Duarte | United States | 36 |
| 10 | Los Angeles | United States | 36 |
Terminations
- Terminated
- 76
- Withdrawn
- 24
- Stopped for recruitment
- 7.5%39 of 520 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT04947618 Terminated | Terminated | The doctor retired and there's no one to take over the project | 2026-06-29 |
| NCT03506373 Terminated | Terminated | Discontinued after interim analysis for futility; no treatment successes observed in the first 12 patients | 2026-02-03 |
| NCT02298816 Withdrawn | Withdrawn | No patients enrolled | 2025-12-31 |
| NCT03246906 Terminated | Terminated | Study was terminated prior to enrolling protocol target accrual goal due to declining accrual and Data Safety Monitoring Board recommendations. | 2025-05-03 |
| NCT01198067 Terminated | Terminated | \<75% participant accrual | 2025-05-02 |
| NCT05537766 Terminated | Terminated | Sponsor decision to terminate study. | 2025-01-27 |
| NCT04635683 Withdrawn | Withdrawn | Investigational Drug removed from the market | 2024-12-31 |
| NCT03333486 Terminated | Terminated | Futility analysis determined closure | 2023-08-28 |
| NCT04804254 Terminated | Terminated | Strategic considerations | 2023-01-11 |
| NCT03225716 Terminated | Terminated | Sponsor decision to end follow-up early | 2022-12-31 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above:
Search all Waldenstrom Macroglobulinemia trials on ClinicalTrials.gov →