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Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning
Phase 2 trial testing Fludarabine monophosphate in Leukemia in 201 participants. Completed in 11 August 2022.
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 201 |
| Start date | 11 April 2012 |
| Primary completion | 11 August 2022 |
| Estimated completion | 11 August 2022 |
| Sites | 1 location across United States |
M.D. Anderson Cancer Center — full company profile →
Adults 5 to 75, any sex, with Leukemia or Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants expired within the first 100 days after transplant not due to relapsed disease.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l | 2 | |
| Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l. | 8 |
Number of participants that are disease free and alive one year post transplant.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l | 29 | |
| Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l. | 93 |
Number of participants that were diseased free and alive 3 years post-transplant.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l | 16 | |
| Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l. | 47 |
Time frame: Adverse events were collected up to 3 years post transplant.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm 1: Participants w/Hema… | Arm 2: Participants w/Hema… |
|---|---|---|---|
| Bacterial Infections | Infections and infestations | — | — |
| Skin GvHD | Skin and subcutaneous tissue disorders | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| GI GvHD | Gastrointestinal disorders | — | — |
| Liver GvHD | Hepatobiliary disorders | — | — |
| Viral Infections | Infections and infestations | — | — |
| Transcient Secondary graft failure | Blood and lymphatic system disorders | — | — |
| VOD/SOS | Hepatobiliary disorders | — | — |
| ABO incompatibility | Blood and lymphatic system disorders | — | — |
| Sepsis like syndrome | General disorders | — | — |
| Elevated bilirubin | Hepatobiliary disorders | — | — |
| Chronic lung GvHD | Respiratory, thoracic and mediastinal disorders | — | — |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | — | — |
| Delayed engraftment | Blood and lymphatic system disorders | — | — |
| Primary graft failure | Blood and lymphatic system disorders | — | — |
| Low Platelet | Investigations | — | — |
| Fungal Infections | Infections and infestations | — | — |
| Parasite Infections | Infections and infestations | — | — |
| HSCT related microangiopathy (TA-TMA) | Blood and lymphatic system disorders | — | — |
| Oral mucositis | Gastrointestinal disorders | — | — |
| Polyneuropathy | Musculoskeletal and connective tissue disorders | — | — |
| Diverticulitis/neutropenic colitis | Gastrointestinal disorders | — | — |
| Autoimmune hemolytic anemia | Immune system disorders | — | — |
| Reaction | System | Arm 1: Participants w/Hema… | Arm 2: Participants w/Hema… |
|---|---|---|---|
| Mucositis | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Bacterial Infections | Infections and infestations | — | — |
| Fluid overload | General disorders | — | — |
| Viral Infections | Infections and infestations | — | — |
| Elevated bilirubin | Investigations | — | — |
| Hypertension | Vascular disorders | — | — |
| Elevated transminitis | Investigations | — | — |
| Neutropenic fevers | Blood and lymphatic system disorders | — | — |
| Liver GvGHD | Investigations | — | — |
| Liver GvHD | Hepatobiliary disorders | — | — |
| GI GvHD | Gastrointestinal disorders | — | — |
| Upper GI GvHD | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Skin GvHD | Skin and subcutaneous tissue disorders | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Chronic ocular GvHD | Eye disorders | — | — |
| Chronic oral GvHD | Gastrointestinal disorders | — | — |
| Renal insufficiency | Renal and urinary disorders | — | — |
| BK virus assoiated Hemorrhagic cystitis | Infections and infestations | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Chronic lung GvGHD | Respiratory, thoracic and mediastinal disorders | — | — |
| Fungal Infections | Infections and infestations | — | — |
| Dysrhythmia | Cardiac disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Fevers | General disorders | — | — |
| Encephalopathy | Psychiatric disorders | — | — |
| Ejection fraction decreased | Cardiac disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| PRES | Nervous system disorders | — | — |
| Autoimmune hemolytic anemia | Investigations | — | — |
| Chronic Skin GvHD | Skin and subcutaneous tissue disorders | — | — |
| Chronic GvHD | Musculoskeletal and connective tissue disorders | — | — |
| Chronic vaginal GvHD | Reproductive system and breast disorders | — | — |
| Red cell dysplasia due to major ABO incompatibility | Investigations | — | — |
| ABO incompatibility | Investigations | — | — |
| Hemorrhagic cystitis | Renal and urinary disorders | — | — |
| Chronic GvHD_Serositis | Respiratory, thoracic and mediastinal disorders | — | — |
| BOOP | Respiratory, thoracic and mediastinal disorders | — | — |
| Diverticulits/colitis | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Bacterial Infections, Skin GvHD, Pneumonitis, GI GvHD, Liver GvHD, Viral Infections, Transcient Secondary graft failure, VOD/SOS.
Data from ClinicalTrials.gov NCT01572662 adverse events section.
The goal of this clinical research study is to learn if giving busulfan and fludarabine before a stem cell transplant can help control the disease better than the standard method in patients with leukemia, lymphoma, multiple myeloma, MDS, or MPD. In this study, 2 doses of busulfan will be given 2 weeks before a stem cell transplant followed by 4 doses of busulfan and fludarabine during the week before the stem cell transplant, rather than the standard method of giving 4 doses of busulfan and fludarabine only during the week before the stem cell transplant. The safety of this combination therapy will also be studied. Busulfan is designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die. Busulfan is commonly used in stem cell transplants. Fludarabine is designed to interfere with the DNA of cancer cells, which may cause the cancer cells to die.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing