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Anti-metabolites

Thiotepa + Fludarabine + Melphalan for Leukemia

Phase 2
Waitlist Available
Led By Leland Metheny, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with specific hematologic malignancies including AML, ALL, MDS, Mixed Phenotypic Leukemia, CML, Myelofibrosis, and Relapsed or Refractory Lymphoid Malignancies
Patients with specific HLA matching criteria or a related haplo-identical donor
Must not have
Patients with inadequate Organ Function including specific criteria for creatinine clearance, bilirubin levels, liver enzymes, pulmonary function, cardiac function, and performance status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year after transplant
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate whether combining thiotepa with melphalan and fludarabine is a safe and effective reduced intensity conditioning regimen for alternative donor transplants.

Who is the study for?
This trial is for patients with certain blood cancers like leukemia, myelodysplasia, or lymphoma who don't have a matched donor. They should be in remission or have minimal disease after treatment and must not be pregnant. Participants need to be fairly active (ECOG ≤ 2) and able to understand the study.
What is being tested?
The trial tests a combination of Thiotepa, Melphalan, and Fludarabine as pre-treatment before receiving stem cells from alternative donors like umbilical cord blood or half-matched relatives. It aims to see if this regimen is safe/effective for high-risk patients without standard donors.
What are the potential side effects?
Possible side effects include nausea, vomiting, mouth sores (mucositis), low blood counts leading to infection risk, liver problems (elevated bilirubin/AST/ALT), kidney issues (reduced creatinine clearance), lung function decrease (DLCOc <60%), and heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a specific blood cancer such as AML, ALL, or CML.
Select...
I have a donor who is a perfect match or nearly matches my genetic makeup.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My organ functions, including kidney, liver, lung, heart, and overall health status, meet the required levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year after transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of patients with leukemia free survival
Secondary study objectives
Average overall survival
Incidence of acute GVHD
Incidence of chronic GVHD
+4 more

Side effects data

From 2022 Phase 3 trial • 665 Patients • NCT00567567
84%
58300-Neutrophil count decreased
70%
65800-Platelet count decreased
20%
43100-Hypokalemia
18%
44800-Infections and infestations - Other specify
18%
33300-Febrile neutropenia
17%
88500-White blood cell decreased
13%
13200-Anemia
9%
55600-Mucositis oral
7%
42700-Hypocalcemia
7%
13500-Anorexia
7%
11600-Alanine aminotransferase increased
7%
41400-Hyperglycemia
6%
15000-Aspartate aminotransferase increased
6%
43300-Hyponatremia
6%
73700-Sepsis
6%
53700-Lymphocyte count decreased
4%
25700-Diarrhea
3%
65900-Pleural effusion
3%
57600-Nausea
3%
37500-GGT increased
3%
41600-Hyperkalemia
3%
10300-Abdominal pain
3%
20500-Catheter related infection
3%
59700-Oral pain
2%
38900-Hearing impaired
2%
43900-Hypoxia
2%
17200-Blood and lymphatic system disorders - Other specify
2%
14900-Ascites
2%
75700-Small intestinal obstruction
2%
87900-Vomiting
2%
43600-Hypotension
1%
45800-INR increased
1%
34000-Fibrinogen decreased
1%
23000-Confusion
1%
42600-Hypoalbuminemia
1%
69700-Rash maculo-papular
1%
71500-Respiratory failure
1%
73900-Serum amylase increased
1%
26600-Duodenal obstruction
1%
66300-Pneumonitis
1%
58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify
1%
56600-Myelitis
1%
75600-Small intestinal mucositis
1%
66800-Postoperative hemorrhage
1%
43500-Hypophosphatemia
1%
37300-Generalized muscle weakness
1%
81200-Treatment related secondary malignancy
1%
31200-Esophagitis
1%
83100-Urinary tract infection
1%
24100-Creatinine increased
1%
11100-Acute kidney injury
1%
62600-Pelvic pain
1%
65300-Pharyngolaryngeal pain
1%
31900-Eye disorders - Other specify
1%
10900-Activated partial thromboplastin time prolonged
1%
11800-Alkaline phosphatase increased
1%
42500-Hyperuricemia
1%
17400-Blood bilirubin increased
1%
63100-Pericardial effusion
1%
72700-Right ventricular dysfunction
1%
37200-General disorders and administration site conditions - Other specify
1%
40000-Hepatic failure
1%
88200-Weight gain
1%
41300-Hypercalcemia
1%
54900-Metabolism and nutrition disorders - Other specify
1%
71000-Renal and urinary disorders - Other specify
1%
69000-Pulmonary hypertension
1%
20100-Cardiac disorders - Other specify
1%
22100-Colitis
1%
44200-Ileal obstruction
1%
81900-Typhlitis
1%
33900-Fever
1%
35500-Gallbladder pain
1%
40600-Hepatobiliary disorders - Other specify
1%
66500-Portal hypertension
1%
12000-Allergic reaction
1%
13100-Anaphylaxis
1%
44700-Immune system disorders - Other specify
1%
13400-Anorectal infection
1%
25600-Device related infection
1%
29500-Enterocolitis infectious
1%
53100-Lung infection
1%
62500-Pelvic infection
1%
75200-Skin infection
1%
82300-Upper respiratory infection
1%
14500-Arterial injury
1%
15300-Ataxia
1%
38800-Headache
1%
63900-Peripheral motor neuropathy
1%
11300-Adult respiratory distress syndrome
1%
29700-Epistaxis
1%
78100-Stridor
1%
68400-Pruritus
1%
51700-Left ventricular systolic dysfunction
1%
27800-Dyspnea
1%
58100-Nervous system disorders - Other specify
1%
29000-Encephalopathy
1%
42100-Hypertension
1%
24700-Dehydration
1%
43200-Hypomagnesemia
1%
31800-Extrapyramidal disorder
1%
52600-Lipase increased
1%
10700-Acidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tandem HST (CEM), Randomly Assigned
Single HST (CEM)
Not Assigned

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Thiotepa + Fludarabine + MelphalanExperimental Treatment3 Interventions
Melphalan 100 mg/m2 on day -8 Thiotepa 10 mg/kg on day -7 Fludarabine 160 mg/m2 in divided doses given on days -6, -5, -4 and -3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan
2008
Completed Phase 3
~1500
Thiotepa
2008
Completed Phase 3
~2120
Fludarabine
2012
Completed Phase 4
~1830

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
469 Previous Clinical Trials
33,430 Total Patients Enrolled
36 Trials studying Leukemia
1,664 Patients Enrolled for Leukemia
Leland Metheny, MDPrincipal InvestigatorCase Comprehensive Cancer Center
8 Previous Clinical Trials
116 Total Patients Enrolled
3 Trials studying Leukemia
70 Patients Enrolled for Leukemia

Media Library

Fludarabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03342196 — Phase 2
Leukemia Research Study Groups: Thiotepa + Fludarabine + Melphalan
Leukemia Clinical Trial 2023: Fludarabine Highlights & Side Effects. Trial Name: NCT03342196 — Phase 2
Fludarabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03342196 — Phase 2
~5 spots leftby Dec 2025
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