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Table 2 Modality and dose of GO therapy and treatment responses in 12 children with relapsed/refractory myeloid leukemia

From: Efficacy and tolerability of gemtuzumab ozogamicin (anti-CD33 monoclonal antibody, CMA-676, Mylotarg®) in children with relapsed/refractory myeloid leukemia

Nr

Disease status

Nb of GO courses

GO dose/course

BM before GO % *

Diag/GO (days)

Response

GO toxicity (NCI-CTC) ¥

Further treatment

Follow-up

#1

De novo refractory

1

1 × 9 mg/m2 (d1)

40

335

DP

Anaphylaxis

Transient grade IV hyperbili.

Grade III transa. elevation

None

V from JMML

#2

Refractory relapse

1

1 × 9 mg/m2 (d1)

98

250

DP

No

None

V from AML

#3

Post-SCT 2nd relapse

1

3 × 3 mg/m2 (d1,d4,d7)

49

555

DP

Grade III febrile neutropenia

Grade III transa. elevation

None

V from AML

#4

Refractory relapse

1

3 × 3 mg/m2 (d1,d4,d7)

43

177

DP

Grade II vomiting

Grade III febrile neutropenia

Grade II stomatitis

None

V from AML

#5

De novo refractory

1

3 × 3 mg/m2 (d1,d4,d7)

45

667

CRp (d28)

No

MUD-SCT

V from SCT

#6

Refractory relapse

1

3 × 3 mg/m2 (d1,d4,d7)

73

579

DP

Grade II stomatitis

None

V from AML

#7

De novo refractory

1

1 × 9 mg/m2 (d1)

59

145

DP

Septic shock

Grade II vomiting

Grade I fever

None

V from AML

#8

Refractory relapse

1

3 × 3 mg/m2 (d1,d4,d7)

96

298

DP

Grade II vomiting

Grade I fever

None

V from AML

#9

Refractory relapse

2

3 × 3 mg/m2 (d1,d4,d7) and 2 × 3 mg/m2

86

162

CR (d39)

No

MUD-SCT

V from AML §

#10

Refractory relapse

1

2 × 9 mg/m2 (d1,d14)

25

357

DP

Grade III febrile neutropenia

Grade II transa elevation

Grade II hyperbilirubinemia

Grade III acute cholecystitis

Grade IV hemorragic cystitis

None

V from AML

#11

Refractory relapse

1

2 × 7.5 mg/m2 (d1,d16)

20

513

CRp (d24)

Grade II fever

Grade II vomiting

Haplo-SCT

V from AML

#12

Refractory relapse

1

6 mg/m2 (d1)+9 mg/m2 (d16)

35

1367

DP

Grade II pancreatitis

Grade II fever

Grade II vomiting

Arsenic clofarabin.

Alive in PR ♣

  1. BM: bone marrow; SCT, stem cell transplantation; MUD, matched unrelated donor; CR, complete remission; CRp, complete remission without total platelet recovery; PR, partial remission; DP, disease progression.
  2. *Bone marrow blast percentage. CD33 expression was greater than 20% before GO in all cases.
  3. ¥All patients experienced NCI-CTC grade III to IV hematological toxicity, which is not mentioned here.
  4. ‡This patient was treated with 3 × 3 mg/m2 of GO leading to a reduction in BM blasts from 86 to 20% at d28. Because of good tolerance, two more doses of 3 mg/m2 were administered and CR was obtained at d39.
  5. §This patient relapsed 69 days after MUD-SCT but a drastic reduction of BM blasts was obtained with 5 weekly doses of 3 mg/m2 GO without any significant adverse effects. He received GO maintenance therapy but died 12 months after MUD-SCT.
  6. V Death
  7. ♣ This patient was scheduled to receive MUD-SCT.